Comparison Between the Use of Music and Relaxation Training on Craving Alcohol in Patients With Alcohol Dependence Syndrome: A Pilot Study
Phase: NA
Conditions: Alcohol Dependence Syndrome
Sponsor: Kasturba Medical College

Title: Comparison Between the Use of Music and Relaxation 
Training on Craving Alcohol in Patients with Alcohol 
Dependence Syndrome: 
A Pilot Study 
 
NCT No: NCT04351217 
 
By Shradha Chandrasekar 
 
Date: 16 January, 2019 

 
 
Department of Psychiatry, Kasturba Medical College,  
Mangalore, Karnataka, India 
 
 
Comparison Between the Use of Music and Relaxation Training on 
Craving Alcohol in Patients with Alcohol Dependence Syndrome:  
A Pilot Study 
 
 
 
By Shradha Chandrasekar 
 
Under the Guidance of: Dr Keshava Pai,  
Professor and Head, Dept of Psychiatry  
KMC Mangalore 
 
 
NCT No.: NCT04351217

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
2 
 
Table of Contents 
 
S. No. 
Topic 
Page No. 
1. 
Introduction 
3 
2 
Review of Literature 
9 
3 
Rationale of the Study 
12 
4 
Need for the Study 
13 
5 
Methodology 
14 
6. 
Procedure 
17 
7 
References 
20 
8 
Appendix 
24 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
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Introduction 
Alcohol Dependence Syndrome (ADS) 
A cluster of physiological, behavioural, and cognitive phenomena in which the use of 
a substance (here, alcohol) or a class of substances takes on a much higher priority for a given 
individual than other behaviours that once had greater value. 
Diagnostic guidelines include 
1. Strong desire or sense of compulsion to take substance; 
2. Difficulties in controlling substance-taking behaviour in terms of its onset, 
termination, or levels of use;  
3. A physiological withdrawal state  
(Includes symptoms experienced in the Head: headaches, dizziness; Chest: Chest tightness, 
difficulty breathing; Heart: Racing heart, skipped beats, palpitations; GI: Nausea, vomiting, 
diarrhoea, stomach aches; Muscles: Muscle tension, twitches, tremors, shakes, muscle aches; 
Skin: Sweating, tingling. 
The sudden cessation of use of alcohol or tranquilizers can cause seizures, strokes, or 
heart attacks in high risk patients. A medically supervised detox can minimise an individual’s 
symptoms of withdrawal and decrease the risk of possible complications. Some of the 
potentially hazardous symptoms of alcohol and tranquillizer withdrawal are: Grand mal 
seizures; Heart attacks; Strokes; Delirium tremens, Hallucination.(1);  
4. Evidence of tolerance; 
5. Progressive neglect of alternative pleasures or interests because of substance use; 
6. Persisting with use despite clear evidence of overtly harmful consequences  
 
 

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
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Skinner and Allen (1982) found that clinicians treating patients with Alcohol 
Dependence often find that their patients report symptoms and signs that are very different 
from what the textbooks describe. 
Despite this, certain elements have been grouped as essential in ADS. These include: 
o Narrowing in the repertoire (internal and external cues to drink) of drinking behaviour 
o Salience of drink-seeking behaviour 
o Increased tolerance to alcohol 
o Repeated withdrawal symptoms 
o Repeated relief from/avoidance of withdrawal symptoms by drinking 
o A subjective awareness of a compulsion to drink 
o Relapse of the syndrome after a period of abstinence 
Moreover, these elements vary in the degree to which they are present or experienced, and 
thus the syndrome has a range of severity. Further, they characterise dimensions along which 
clinicians can organise the information obtained from the patient (2). 
Craving 
Craving is “aversive, confusing, intrusive, frustrating, and exasperating”. It can 
control thoughts and tends to keep people awake at night, even causing irrational words and 
actions from people who might otherwise be reasonable. 
A number of addiction theorists hypothesise that craving plays an important role in 
both acquisition and maintenance of dependence on a drug, like alcohol. 
Tiffany and Conklin (2000) theorised that craving has two prominent features: 
1. It tends to be highly situational i.e. specifically and easily triggered by stimuli that 
have earlier association with use of alcohol. 
2. Its experience can persist beyond the point of abstinence/cessation of drinking. (3) 
 

 
 
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Coping with Craving 
 
Since craving has been described as aversive, an obvious corollary is that individuals 
who experience craving will find some ways to cope with the craving. 
 
Coping refers to “behaviour that protects people from being harmed by problematic 
[social] experience”. It consists of behaviour(s) that mediate the impact of issues like alcohol 
withdrawal, stress, societal restrictions, aggression, etc. on individuals. 
Pearlin and Schooler (1978) theorise that coping behaviour(s) perform their protective 
functions in one of three possible ways –  
1. Removing or changing conditions that give rise to the problem 
2. “Perceptually controlling the meaning” of an experience in a way that neutralises or 
diffuses the aspect of the experience that is problematic. 
3. Ensuring that the emotional consequences of the problem are kept within 
“manageable bounds”. (4) 
According to Fryndenberg & Lewis (2011), coping strategies can be both Productive and 
Unproductive. 
o Productive Coping Strategies – These entail dealing with the problem, and finding 
ways to protect self from the psychologically damaging consequences of a particular 
emotion/situation/event, while simultaneously making the attempt “to remain 
physically active and socially connected”. 
Some examples include seeking social support, focussing on solving the problem, relaxation 
techniques, physical recreational activities like sports, relaxing diversions like art and dance, 
acceptance, and seeking professional help. 
o Negative Coping Strategies – These generally encompass the use of avoidance 
strategies. These are usually associated with reduced ability or lack of ability to cope 
with stressors. 

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
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Some examples include worrying, wishful thinking, ignoring the problem, withdrawing from 
social circle, self-blame, and acting out. (5) 
Jacobsen’s Progressive Muscle Relaxation (JPMR) 
“An anxious mind cannot exist in a relaxed body”. This quote by Dr Edmund 
Jacobson, is the basis for JPMR.  (6) 
It is the therapeutic technique of choice for use in stress and anxiety management. 
JPMR was created such that it would eventually be something that the practitioner [i.e. 
patient] would be able to automatically and unconsciously monitor and release unwanted 
tension.  
The technique includes the “Tension–Release” cycle (e.g. make a tight fist and then 
release) which has been combined with a focus on breathing. It is aimed at getting in touch 
with the individual’s tension and the body’s response, and then letting it go in a controlled 
manner.  
Freeman (2001) suggests that PMR and other muscle-based relaxation variations 
convey health benefits in three ways:  
1. Utilizing the effects of PMR to manipulate autonomic responses  
2. Increases or activates the production of opiates  
3. Promotes optimal immune function 
The PMR method - strong record of clinical efficacy, acknowledged as standard 
strategy for a number of somatic states, including anxiety and stress. (7) 
Music 
Music is a “dynamic medium” that is used for inspiration, and relaxation, often on a 
daily basis, by many people. With this as the basis, music now plays a larger role in health 
and healing. Music therapy or music-based interventions are an alternative treatment route 

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
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focussed on helping patients deal with physical, emotional, and cognitive problems. It aims to 
enhance social or interpersonal, affective, cognitive, and behavioural functioning. 
Research also shows that music is also effective at reducing muscle tension and anxiety and 
promotes relaxation, verbalisation, group cohesiveness and interpersonal relationships (8)  
In the theory of music literature, the core assumption is on the functions of music. 
Music is generally composed or played for emotional expression. It is used to contain 
behaviours, and trigger cognitions. A 2007 study with adolescents found that apart from 
entertainment, healthy individuals used music to relax, distract themselves from certain 
emotions, or even to discharge these emotions, energise themselves, offer comfort or solace. 
Music is found to provoke sensory images within individuals - the strength of which differs 
from person to person. 
Music also works in enabling people to sense, recognise, and express inner physical, 
psychological, emotional, or cognitive motions that play a role in their daily lives. 
The creation of music leads to expression and containment of the emotions at the same time. 
This is termed the containing power of music. 
Society often frowns upon the expression of certain emotions like anger through 
aggression. Music has the power to let people experience emotion and express it without 
acting on it in reality. 
Thus, music therapy works by applying the containing power of music and its psycho-
bio-social aspects in a systematic manner to influence people (9) 
Studies have demonstrated neurological pathways that imply application of music 
therapy in individuals with substance abuse problems, since, music stimulates brain processes 
that affect the production of certain endorphins in receptors (DRD2). The long-term use of 
substances severely impairs and/or damages these pathways. (8) 

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
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In a 2001 study by Daveson and Edwards, female inmates in jail reported that felt 
more relaxed, less stressed, and could express themselves better after 12 music therapy 
sessions. Patients also indicate reduction in anger, stress and frustration. Thus, research has 
indicated that music therapy or music-based interventions can help to move coping skills 
from mainly aggressive behaviour to general behaviour (10) 
 
 

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
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Review of Literature 
Alcohol and Stress 
(In the literature, stress is used as an umbrella term for anxiety, tension, stress, defensiveness, 
and associated feelings.) 
Fox et al (2007) conducted a study with 20 treatment seeking ADS patients using 
guided imagery to imagine a “recent personal stressor, personal alcohol cue-related stressor, 
and a neutral imagery situation” over 3 sessions, one per session in random order. Exposure 
to stress and to alcohol cues each produced significant increases in alcohol craving, anxiety, 
and negative emotions and decreases in positive emotions.  
Stress‐induced alcohol craving was significantly correlated with increases in sadness, 
anger, and anxiety ratings, but alcohol cue‐induced craving was associated with decreases in 
positive affect (joy and neutral relaxed state) and increases in anxiety and fear ratings. (11) 
 
Duka et al. (2006) found in patients with multiple episodes of withdrawals from 
alcohol, associated craving, and anxiety. (12) 
 
 
In a similar study conducted in 2000 by Sinha et al., it was observed that there were 
significant increases in the level of cocaine and alcohol craving with stress and drug cues 
imagery but not with neutral-relaxing imagery.  
They also found that similar increases in subjective anxiety, heart rate and salivary 
cortisol levels are produced by stress and drug cues. 
It was also found that there are significant increases in ratings for negative emotions 
and decreases in ratings for positive emotion for stress and drug cue conditions as 
compared to the neutral condition. (13) 
 

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
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Alcohol, Stress, and Relapse 
 
In the 2004 meeting of the Research Society on Alcoholic Meeting Symposium, Sinha 
presented clinical evidence that increased sensitivity to craving increases risk for relapse; 
stress can cause anxiety like symptoms through craving; and that there is sufficient evidence 
to conclude that stress is involved in a relapse. (14)  
 
Sinha and Li (2006) found that major factors contributing to high rates of relapse are 
stress and drug related cues. Further, there is an overlap in the brain areas that process stress 
and drug cue-induced craving, including in the medial prefrontal cortex, anterior and 
posterior cingulate cortex, striatal and postular insula regions; and these regions have been 
associated with craving state and increased susceptibility to relapse. (15) 
Craving and Stress 
 
Gruser, Morsen and Flor (2006) conducted a study on the level of craving in 50 
problem drinkers, and occasional drinkers. The problem drinkers were found to have higher 
amount of craving accompanied by increased stress-distress; along with a higher tendency to 
use inadequate (negative) coping strategies.  
Further, craving was found to be a significant predictor of craving. They concluded 
that there needs to be a focus on alternative coping strategies that would be beneficial in the 
management of craving. (16) 
 
Dharmadhikari and Sinha (2015) described craving as the psychic pain of addiction, 
and that it was the obstacle to abstinence. Craving is what turns drug-taking behaviour into 
compulsive drug-taking behaviour. (17) 
 
Swift and Stout (1992) found that craving and anxiety stress share many similar 
attributes, including comparable response to pharmacological agents. In their work with 32 

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
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patients who used opioids, they found the highest positive correlation between anxiety and 
craving. (18) 
Coping with Stress and Use of Music  
 
Labbe et al. (2007) hypothesised that listening to relaxing classical music after being 
exposed to a stressor should result in “significant reductions in anxiety, anger, and 
sympathetic nervous system arousal, and increased relaxation compared to those who sit in 
silence or listen to heavy metal music”. Their results indicated that listening to classical 
music, after exposure to a stressor, significantly reduces negative emotional states and 
physiological arousal compared to listening to heavy metal music or sitting in silence. (19) 
 
A meta-analysis of 22 studies by Pelletier (2004), showed that arousal due to stress is 
significantly reduced with music and music assisted relaxation techniques. Stress, including 
anxiety, fear, and tension, was found to significantly influenced by music, and strong positive 
correlations were observed with increased relaxation and the playing of music. 
The strongest correlations were found with classical, instrumental music without 
lyrics, and with regular, rhythmic patterns, and no extreme changes (e.g. a beat drop). (20) 
 
In a 2001 study by Knight and Rickard, they exposed 87 participants to a cognitive 
stressor task, either in presence of classical, instrumental music, or in silence. When the two 
groups were compared on physiological and subjective (psychological) measures of anxiety, 
it was found that exposure to music prevented stress induced stress induced physical arousal, 
and thus music acts as an effective anxiolytic. (21) 
 
 

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
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Alcohol and Music  
 
Silverman found significant difference in the readiness to change alcohol-use 
behaviours between patients who were given music-based interventions and verbal therapy. 
Though not significant, the patients in the music group were also found to have lower craving 
scores. (22) 
Stress and PMR  
 
In 2015, Kaur and Kaur found that PMR was effective in reducing stress levels of 
patients admitted for alcohol deaddiction, significant at 0.05 level. (23) 
In her 2014 study with staff nurses in Vadodara, Patel found significant reduction in 
stress levels experienced by nurses with the use of Progressive Muscle Relaxation through 
pre- and post-test measures. (24) 
 
Bommareddi et al. (2014) conducted a study with 30 patients who are living with 
HIV, 13% of whom had abnormal anxiety, and the rest has the increased stress levels 
associated with living with HIV. Comparing pre- and post-test measures of stress with the use 
of PMR, the reduction in stress levels was found to be significant at 0.001 level. (25) 
Rationale of the Study 
Music is an adaptive, emotion-based coping strategy, and research has shown that 
music-based interventions have a positive effect on levels of stress, aggression, and 
frustrations. Since these emotions are also associated with craving, this study aims to find if 
music will work in a similar manner to help patients deal with craving for alcohol.  
The control technique of JPMR is selected based on research evidence that indicates 
its benefit with the management of stress, anxiety, depression, aggression, and frustration.  

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
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Need for the Study 
As seen through the review of literature, alcohol craving and stress and correlated 
with relapse. Further, the use of music has demonstrated significant reduction in the level of 
stress experienced across various clinical and non-clinical populations.  
GAP IN THE KNOWLEDGE  
Though there are studies on use of music to cope with cocaine withdrawal, there is no 
study conducted, especially in the Indian scenario, on the effect of music on coping with 
craving alcohol. 
If the effect is found to be significant, it can create an avenue for further research, and 
provide a simple, cost-free addition to treatment of patients with ADS. 
 
 

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
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Methodology 
Aim 
To compare the effectiveness of music and progressive muscle relaxation on craving  
alcohol and perceived ability to cope with craving in patients with alcohol dependence  
syndrome.  
Objectives  
1. To compare the pre and post-test measures of craving and coping for the two groups  
(within groups).  
2. To check the difference in the pre and post-test measures of craving and coping in the  
two groups (between groups).  
3. To analyse the responses obtained through a Single Question Exit Interview, to  
understand patients’ subjective perception about the music and the muscle relaxation 
Hypothesis 
1. There is no difference in the effectiveness of music and progressive muscle relaxation  
on craving alcohol  
2. There is no difference in the effectiveness of music and progressive muscle relaxation  
on perceived ability to cope with craving alcohol. 
Sampling 
• Size – 10 patients in each group, so a total of 20 patients will be selected.  
• Method – Purposive sampling will be used.  

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
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• Design – Randomized parallel intervention trial  
• Criteria  
o Inclusion criteria  
▪ Patients with ADS 
▪ Adults in the age range of 18-60, of either gender  
▪ Abstinent for at least 1 week  
o Exclusion criteria  
▪ Any other known psychiatric disorder/severe medical condition 
▪ Use/abuse of substances other than alcohol and nicotine  
▪ At risk for self-harm or suicide  
o Drop-out criteria  
▪ Less than 75% compliance  
▪ Relapse (defined as a return to drinking behaviour)  
 The study duration will be 1 year, conducted on patients from Mangalore. 
Tools to be used in the study  
 Three scales will be used in the study, along with a single question exit interview. Further,  
recorded versions of music and PMR will be used to ensure uniformity in delivery of the  
intervention.  
1. URICA Scale  
 The University of Rhode Island Change Assessment (URICA) Scale is designed to assess the 
change readiness of an individual. It acts as a screening tool for assessment of the stage of 
change a patient with ADS is at, based on Prochaska’s Transtheoretical Model of Change. 
The scale has been found to have excellent reliability and was a significant predictor of 

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
16 
 
treatment dropout and retention. The scale also showed moderate reliability as a predictor of 
patient prognosis. (26,27) 
2. Alcohol Urge Questionnaire (AUQ)  
 The AUQ is a self-report measure of craving alcohol, with eight items, with high internal 
consistency (0.91); and high test-retest reliability of 0.82 after 24 hours; as well as suitable 
construct validity. (28) 
3. Visual Analogue Scale (VAS)  
The VAS is a line 100mm in length, with both the ends indicating extremes of the construct 
being assessed. Used generally to assess pain, VAS measures have been found to be reliable 
and valid measures of a number of constructs as needed. The VAS used here ranges from 
Completely Unable to Cope and Completely Able to Cope. The patient will indicate their 
subjective perception of their own ability to cope with craving alcohol.  
4. Single Question Exit Interview (SQI)  
 Each patient will be asked a single question during the final debriefing on the last day of the 
study. The question will be “Please describe your experience with the music/exercise”. Their 
answers will be recorded verbatim and will be translated from Kannada as needed.  
5. The music  
Based on the reviewed literature, Raga Bhairavi and Ahir Bhairav, played on the flute with 
no lyrics sung will be used in the study. (20,29–31) 
The music will be played to the patients through a speaker, keeping the volume constant  
across all patients.  
 

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
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6. The Progressive Muscle Relaxation  
A twenty-minute PMR based on Jacobsen’s Progressive Muscle Relaxation was developed 
and will be recorded in English and Kannada. (32) This will be done to ensure uniformity of 
delivery of instructions across patients.  
Procedure  
Ethical approval will be sought from the Institutional Committee. Permission will be 
sought from the head of the rehabilitation facility, as well as from the treating psychiatrist for 
each individual patient. Patients will be recruited at random from the rehabilitation centre. 
After an intake interview to ensure that they meet the required criteria and providing them 
with all the information regarding the study, informed consent will be attained. They will be 
allocated to either the music group or PMR group randomly through a sequence generated 
through the randomizer..  
Then, the URICA will be administered to obtain baseline motivation levels on Day 1, 
followed by AUQ, VAS for Coping. Then the first session of the assigned intervention will 
be conducted. On subsequent days, further sessions of the intervention will be conducted. 
AUQ and VAS measurements will be taken on Day 3 and Day 5.  
Music will be played at a constant volume across days and patients, and the PMR 
sessions will carried out as described above. On the final day, patients will be debriefed about 
the study and the SQI will be conducted.  
 
 

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
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Figure 1: The Process of the Study 
 
 
 
• Patient assigned Subject Code to 
maintain privacy 
• URICA administered 
• AUQ and VAS measures obtained 
• The study explained to the patient 
• Treating psychiatrist consent 
obtained 
• Informed consent obtained 
• Random assignment either to 
music group or PMR group 

The study technique of PMR 
explained to the patient. 

Patient received 4 sessions 
of training in JPMR using the 
recorded instructions 

Patient demonstrated the 
PMR exercise, and errors, if 
any, corrected 
 

The use of music explained to 
the patient. 

Patient heard the music on 
5 consecutive days 
• AUQ and VAS assessed on Day 3 
and Day 5 
• SQI conducted and answers 
recorded 
• Patients debriefed and encouraged 
to continue the exercise after 
completion of the study. 
• AUQ and VAS assessed on Day 3 
and Day 5 
• SQI conducted and answers 
recorded 
• Patients debriefed and encouraged 
to continue listening to the music 
after completion of the study and 
explained how to find the music. 

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
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Analysis of Data 
Data will be analysed using student paired t test (pre- and post-test measures), and student 
unpaired t test (between post-test measures of study and control group. 
Statistical package for social sciences (SPSS) software version 17.0 will be used for analysis 
of the data. 
Ethical considerations 
Ethical considerations of consent, confidentiality, competence, and non-maleficence will be 
adhered to in the strictest of manner 
 Implications 
This study will provide additional information towards reducing relapse in ADS patients. 
This study could provide an easily available, user-friendly tool for reducing relapse in ADS 
patients. This study will add information to the existing pool of literature on coping, craving, 
alcohol dependence, and music as a coping strategy. 
 
 
 

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
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Sci. 2014;2(2):4–8.  
31.  
Scherer KR. Which Emotions Can be Induced by Music? What Are the Underlying 
Mechanisms? And How Can We Measure Them? J New Music Res [Internet]. 2004 
Sep [cited 2018 Nov 18];33(3):239–51. Available from: 
http://www.tandfonline.com/doi/abs/10.1080/0929821042000317822 
32.  
Mushtaq B, Khan AA. Jacobson Muscle Relaxatation Technique (Jpmr) (20 Min) JOJ 
Nurse Health Care. JOJ Nurse Heal Care [Internet]. 2018 [cited 2020 Jan 12];8(1). 
Available from: https://juniperpublishers.com/online-submission.php 
 
 

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
24 
 
Appendix  
1. Client Information Sheet/Informed Consent Form 
2. URICA Scale 
3. AUQ 
4. VAS for Coping 
5. Patient Register 
6. Record Sheet  
7. Randomised list of assigning conditions 
8. Permissions for  
a. URICA 
b. AUQ 
9. Letter of permission from treating psychiatrist  
 
 

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
25 
 
1. Client Information Sheet/Informed Consent Form 
 
KASTURBA MEDICAL COLLEGE, MANGALORE 
DEPARTMENT OF PSYCHIATRY 
SUBJECT INFORMATION SHEET 
Study: Comparison Between the Use of Music and Relaxation Training on Craving 
Alcohol in Patients with Alcohol Dependence Syndrome: A Pilot Study 
Investigator: Shradha Chandrasekar, student, MSc Clinical Psychology, KMC Mangalore. 
Guide: Dr Keshava Pai, Professor and Head, Dept. of Psychiatry, KMC Mangalore. 
 
STUDY AND INVESTIGATORS 
 
This study involves comparison between two techniques to see which works better to 
help cope with alcohol craving. One of the techniques is music, the other is a relaxation 
technique called Progressive Muscle Relaxation. 
 
It is being conducted by Shradha Chandrasekar, student, pursuing MSc Clinical 
Psychology at Kasturba Medical College, Mangalore, under the guidance of Dr Keshava Pai, 
professor and Head of Department of Psychiatry at Kasturba Medical College, Mangalore.  
 
Your participation in this study is wholly voluntary, and you should only agree to it 
after reading the following information and clarifying any queries you may have. 

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
26 
 
 
PROCEDURE OF THE STUDY 
 
If you agree to participate in this study, you will be assigned either of the two 
techniques randomly. You will be explained how the technique assigned to you is to be used. 
Your urge to drink and how well you think you can cope with it will be assessed on this first 
day. 
At three days, and then again at five days, your craving and coping  again be assessed.  
 
BENEFIT OF THE STUDY 
When the techniques are found to be useful, they can be used as an additional 
treatment tool in therapy of patients with alcohol dependence. 
SAFETY INFORMATION 
Both techniques are non-invasive and will not produce any side-effects. 
RISKS AND DISCOMFORT 
However, if at any point during the study you feel uncomfortable, you can contact the 
Investigator (cshradha1@gmail.com) or the Guide (paikeshava@gmail.com ) through email 
or on the KMC Attavar OPD office number 0824 2445858, Extn – 5335, or by asking the 
operator for Psychiatry OPD.  
WITHDRAWAL FROM THE STUDY 
You can withdraw from the study at any point without your medical care or legal 
rights being affected.  
The Investigator or Guide may terminate your participation in the study at any point if 
such a situation may arise. 
 

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
27 
 
CONFIDENTIALITY 
 
All information collected from you will be kept confidential. If the data are used for 
publication in psychological journals, no identifying information of any kind will be used 
with your permission. 
If you agree to participate in the study the Ethics Committee and the regulatory 
authorities will not need your permission to look at your health records both in respect of the 
current study and any further research that may be conducted in relation to it, even if I 
withdraw from the trial. 
 
FURTHER INFORMATION 
 
You may ask any question or clarification or extra information at any point from the 
Investigator or the Guide, and they will be available to answer your questions and concerns.  
You will be given a copy of this sheet and of the Informed consent form for your records. 
 
 

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
28 
 
 
 
KASTURBA MEDICAL COLLEGE, MANGALORE 
DEPARTMENT OF PSYCHIATRY 
INFORMED CONSENT FORM 
SUBJECT COPY 
 
Subject’s Name: ________________  
 
 
Subject’s Initials: ______ 
 
Date of Birth: ___/___/_____  
 
 
 
 
 
Age: ____ 
 
Mobile number:  Subject: __________________  
Caregiver: ___________________ 
Study: Comparison Between the Use of Music and Relaxation Training on Craving 
Alcohol in Patients with Alcohol Dependence Syndrome: A Pilot Study 
Investigator: Shradha Chandrasekar, student, MSc Clinical Psychology, KMC Mangalore. 
Guide: Dr Keshava Pai, Professor and Head, Dept. of Psychiatry, KMC Mangalore. 
I have read/I have been explained the study and I confirm that I have understood the 
information sheet for the study. I also understand that I can contact the Investigator or the 
Guide at any point through email for further clarification/information. 

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
29 
 
I understand that my participation in the study is voluntary and that I am free to 
withdraw at any time, without giving any reason, without my medical care or legal rights 
being affected.  
I also understand that the Investigator or Guide may terminate my participation in the 
study at any point if such a situation may arise.  
I understand that the Ethics Committee and the regulatory authorities will not need 
my permission to look at my health records both in respect of the current study and any 
further research that may be conducted in relation to it, even if I withdraw from the trial.  
However, I understand that my identity will not be revealed in any information 
released to third parties or published. I agree not to restrict the use of any data or results that 
arise from this study provided such a use is only for scientific purpose(s). 
 
    -------------------------------------- 
 
 
       ---------------------------------------- 
Signature/Thumb Impression of  
 
 
     Signature of Investigator with date 
Subject/Legal Representatives with date 
        
Contact details: Investigator: Shradha Chandrasekar  
cshradha1@gmail.com  
  
Guide: Dr Keshava Pai  
 
paikeshava@gmail.com  
 
Office number: 0824 - 2445858, Extn – 5335 

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
30 
 
 
KASTURBA MEDICAL COLLEGE, MANGALORE 
DEPARTMENT OF PSYCHIATRY 
INFORMED CONSENT FORM 
INVESTIGATOR COPY 
 
Subject’s Name: ________________  
 
 
Subject’s Initials: ______ 
 
Date of Birth: ___/___/_____  
 
 
 
 
 
Age: ____ 
 
Mobile number:  Subject: __________________  
Caregiver: ___________________ 
Study: Comparison Between the Use of Music and Relaxation Training on Craving 
Alcohol in Patients with Alcohol Dependence Syndrome: A Pilot Study 
Investigator: Shradha Chandrasekar, student, MSc Clinical Psychology, KMC Mangalore. 
Guide: Dr Keshava Pai, Professor and Head, Dept. of Psychiatry, KMC Mangalore. 
I have read/I have been explained the study and I confirm that I have understood the 
information sheet for the study. I also understand that I can contact the Investigator or the 
Guide at any point through email for further clarification/information. 

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
31 
 
I understand that my participation in the study is voluntary and that I am free to 
withdraw at any time, without giving any reason, without my medical care or legal rights 
being affected.  
I also understand that the Investigator or Guide may terminate my participation in the 
study at any point if such a situation may arise.  
I understand that the Ethics Committee and the regulatory authorities will not need 
my permission to look at my health records both in respect of the current study and any 
further research that may be conducted in relation to it, even if I withdraw from the trial.  
However, I understand that my identity will not be revealed in any information 
released to third parties or published. I agree not to restrict the use of any data or results that 
arise from this study provided such a use is only for scientific purpose(s). 
 
    -------------------------------------- 
 
 
       ---------------------------------------- 
Signature/Thumb Impression of  
 
 
     Signature of Investigator with date 
Subject/Legal Representatives with date 
 Contact details: Investigator: Shradha Chandrasekar 
 
cshradha1@gmail.com  
  
Guide: Dr Keshava Pai  
 
 
paikeshava@gmail.com  
 
Office number: 0824 - 2445858, Extn – 5335 
 
 

 
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41 
 
2. URICA – Change Assessment Scale 

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
42 
 
 

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
43 
 
3. AUQ 
 
 

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
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MUSIC AND JPMR WITH ADS: A PILOT STUDY 
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4. VAS for Coping 
 
 
 
 
Completely 
Unable to Cope 
Completely 
Able to Cope 

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
46 
 
5. Directory 
Patient 
S. No.   
 
 
 
 
 
 
Hospital No.  
Study Code:  
 
 
 
 
 
Initials: 
D.O.B:  
 
 
 
 
 
 
Gender: 
Education:  
 
 
 
 
 
 
Occupation: 
SES:  
 
 
 
 
 
 
Marital Status: 
City of Residence: 
 
 
 
 
 
Mobile:  
Email:  
Caregiver 
Name:  
 
 
 
 
 
 
Relation:  
Education:  
 
 
 
 
 
 
Mobile:  
 
 
 
 
 
Email: 
 
(An Excel sheet will be used to record this information) 
 
 

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
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6. Record Sheet 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
48 
 
7. Randomised list of assigning conditions 
 
 

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
49 
 
8. Permissions  
a. URICA 
 
b. AUQ 
(Please Ctrl+Click on image for original source page) 
 
 
 

 
 
MUSIC AND JPMR WITH ADS: A PILOT STUDY 
50 
 
From  
 
 
 
 
 
 
 
Date: ___ /___ /_____ 
Shradha Chandrasekar 
Department of Psychiatry 
Kasturba Medical College, Mangalore  
 
To, 
_____________________ 
_____________________ 
Re: Request for Permission to Include Patient _________________ in my Study  
Respected sir/ma’am,  
 
I, Shradha Chandrasekar (182199009) of MSc Clinical Psychology, Department of 
Psychiatry, KMC Mangalore, will be conducting a research titled ‘Comparison Between 
the Use of Music and Relaxation Training on Craving Alcohol in Patients with 
Alcohol Dependence Syndrome:  A Pilot Study’. The sample consists of patients with 
alcohol dependence syndrome who have been abstinent for at least one week of either 
gender, aged 18 – 60. It is a Non-randomised, before and after, without control trial. 
 
Patient ________________ meets the criteria of the study and would be a good 
candidate to participate if they so consent. 
 
The research protocol has been approved by the Institutional Ethics Committee 
and a copy of the letter from the same is attached with this letter.  
I, with this, request your permission to include this patient in the research. 
 
Thanking you, 
 
Yours sincerely  
 
 
 
 
_______________________ 
 
 
 
 
 
 
 
Guide and HOD: Dr Keshava Pai  
Shradha Chandrasekar 
 
 
 
Head and Professor 
MSc Clinical Psychology  
 
 
 
Dept of Psychiatry, 
KMC Mangalore 
 
Treating Psychiatrist:  
Name:        ____________________ 
 
 
 
 
 
Signature: _________________ 
 
 
 
 
Date:          ___ /___ /_____