Clinical trial NCT06781866: The Impact of Relaxation Massage Before Bedtime on Sleep Quality and Quantity.
Official title: The Impact of Relaxation Massage Prior to Bed-time on Sleep Quality and Quantity in People with Symptoms of Chronic In-somnia: a Home-Based Sleep Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Massage
Keywords: Relaxation Massage
Manual Massage Therapy
Insomnia
Lead sponsor: University of Thessaly
Sponsor class: OTHER
Collaborators: name: University of Nicosia
First posted: 2025-01-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Manual massage is an effective treatment approach for reducing general stress and promoting an overall sense of wellbeing. Relaxation massage aims to alleviate psychophysiological tension, enhance both blood and lymphatic circulation, and promote mental and physical relaxation. It is particularly beneficial for those with anxiety-related symptoms (such as generalized anxiety dis-order, social anxiety) and sleep disorders, aiming to improve calmness and promote sleepiness. The purpose of the present study is to assess the effectiveness of a single session of relaxation massage prior to bed-time on sleep quality and quantity indices, in individuals with symptoms of chronic insomnia.

Detailed description: Study Design:

The current study will assess the impact of an in-house full-body deep relaxation massage session performed by a professional masseur in objective measurements of sleep quality and quantity in participants suffering from chronic insomnia just before they go to bed.

The volunteers of the current study will participate in 3 different scenarios, each 5 days apart: Scenario 1 is the control session when participants' sleep will be recorded without any massage intervention. Participants will follow their usual bed-time routine.

Scenario 2, participants will receive a deep relaxation massage session lasting 40 min and follow the sleep recording set up before they follow their usual bedtime routine.

Scenario 3, participants will receive a placebo massage session lasting 40 min (oil rubbing application in participants' body places similar to the massage session) and followed by the sleep recording set up before they follow their usual bedtime routine.

Scenarios 2 and 3 take place in random order for every participant.

Methodology The individuals who are suffering from chronic insomnia and scored more than 15 in the Athens Insomnia Scale, will be the target group. All participants will sign an informed consent form in order to participate in the study. The study is approved by the University's Internal Ethics Committee.

Demographic Characteristics: Demographic characteristics include age, gender, race/ethnicity.

Questionnaires Quality of sleep: The Athens Insomnia Scale, Weekly sleep diary and Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep quality and sleep abnormalities.

Relaxation symptoms: The Relaxation State Questionnaire (RSQ) will be used for the assessment of relaxation symptoms.

Quality of life: The SF36QoL questionnaire (SF-36) will be used for the assessment of the levels of quality of life.

Depressive symptoms: The Beck Depression Inventory (BDI) questionnaire will be used for the assessment of depressive symptoms and signs.

Stress: The STATE - TRAIT ANXIETY INVENTORY (STAI) will be used for the assessment of stress levels.

Sleep Quality Assessment: Quality and quantity of sleep will be assessed by an overnight Home Sleep Test (HST) (SOMNOmedics). Specifically, HST records your brain waves, head movement, body position and snore rhythm during the study.

Massage Intervention Relaxation Massage This technique will be performed all over the body. Exclusively, on specific leg muscle groups such as the gastrocnemius, the femoral biceps and quadriceps and in upper body muscle groups such as the triceps, the rhomboid, the deltoid, the trapezius and head areas. We applied slow strokes and deep finger pressure to ease away pain from the deepest layers of their muscles and connective tissues. The total duration of the relaxation massage will be 35-40 minutes.

Procedure Individuals who achieve a score above 15 (on a scale of 1-24 points) and meet all required conditions will participate in the study.

All procedures will be performed in three visits, one week apart (weekly), and take place at each subject's home:

At the first visit, the Home Sleep Test (HST) we will used to conduct an 8 hour overnight sleep recording.

A daily sleep questionnaire will be handed to the participant to fill out for the next 5 consecutive days.

Also, Relaxation State Questionnaire (RSQ) will be handed to the participant to fill out before and after massage protocol.

On the second and third visit, the same process will be repeated.

Statistical Analysis The statistical analysis will be performed using IBM SPSS Statistics version 29.0 (IBM Corporation, Armonk NY, USA). An independent samples t-Test will be used to assess significant differences in basic characteristics between male and female participants. A General Linear Model-Repeated Measures will be used to examine if there are significant differences in the sleep parameters and sleep diary data between the 3 sessions. To assess normality, the Shapiro-Wilk test will be used alongside graphical repre-sentations, including the Normal Q-Q plot, Detrended Normal Q-Q plot, and Box Plot. The significance level is set at 5%. Beyond significance testing (p-value), effect size is also going to be considered to evaluate the magnitude of the effect.

Power Analysis Sample size calculations were conducted using G\*Power 3.1.\[36\] The post-hoc "GLM: Repeated measures, within factors" method was used for the power analysis. Based on an expected medium effect size of 0.25 (Cohen's f), a significance level of α = 0.05, and a desired power (1-β) of 0.82 (82%), the resulting minimum required sample size was calculated to be 20 participants. The critical F-value was 3.16 with (Ndf) = 2 and (Ddf) = 54.

Eligibility criteria: Inclusion Criteria:

* score of ≥16 on the Athens Insomnia Scale (AIS-8)

Exclusion Criteria:

* history of mental illness, dermatological diseases, allergies to massage oil and any acute or chronic condition that would limit the ability of the patient to participate or consent in the study

Primary outcomes:
measure: Sleep Efficiency
timeFrame: 9 hours
Secondary outcomes:
measure: Sustained Sleep Efficiency
timeFrame: 9 hours
Other outcomes:
Locations:
city: Trikala
country: Greece
facility: School of Physical Education, Sports and Dietetics, TEFAA
state: Thessalia
Study officials:
affiliation: University of Thessaly
name: Giorgos Sakkas, PhD
role: STUDY_DIRECTOR
References:
citation: Mai E, Buysse DJ. Insomnia: Prevalence, Impact, Pathogenesis, Differential Diagnosis, and Evaluation. Sleep Med Clin. 2008;3(2):167-174. doi: 10.1016/j.jsmc.2008.02.001. No abstract available.
citation: Buyukyilmaz F, Asti T. The effect of relaxation techniques and back massage on pain and anxiety in Turkish total hip or knee arthroplasty patients. Pain Manag Nurs. 2013 Sep;14(3):143-54. doi: 10.1016/j.pmn.2010.11.001. Epub 2011 Jan 28.