Clinical trial NCT06669338: Effects of Music Therapy and White Noise on Pre-procedural Fear, Anxiety by Elderly Colonoscopy Patients
Official title: The Effect of Music Therapy and White Noise on Pre-procedural Fear, Anxiety and Vital Signs of Elderly Colonoscopy Patients: A Double-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
the Elderly
White Noise
Music Therapy
Fear
Anxiety
Keywords: Colonoscopy;anxiety;fear;vital signs;musictherapy;whitenoise
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: experimental study with three groups.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study was to examine the effect of two different interventions (music therapy and white noise listening) on anxiety, fear and vital signs in elderly patients undergoing colonoscopy.

The study was a double-blind, pre-test and post-test

Detailed description: Colonoscopy patients experience high levels of fear and anxiety due to the procedure. Fear and anxiety can activate the patient's autonomic nervous system, leading to increased sweating, increased heart rate, blood pressure and respiratory rate, and procedure-related complications. Reducing fear and anxiety and relaxing the patient not only prevents potential harm to the patient due to the procedure, but also facilitates the work of the healthcare team performing the procedure and ensures accurate results. In this context, this study aimed to investigate the effects of music therapy and white noise listening on the fear, anxiety and vital signs of patients undergoing colonoscopy.

Eligibility criteria: Inclusion Criteria:

1. The one to be colonoscoped,
2. 65 years of age or older,
3. Participated in the research voluntarily
4. No vision, hearing and perception problems,
5. No communication problems (able to speak Turkish),
6. Those who are hemodynamically stable before colonoscopy,
7. No psychiatric diagnosis, no use of antidepressants, anxiolytics and sedative agents,
8. No analgesic or anesthetic medication 24 hours before the procedure.

Exclusion Criteria:

1. Developing complications during the procedure,
2. Removing the headset during the procedure,
3. Participants with visual and hearing impairment or a medical history of dementia, cognitive impairments or psychiatric disorders
4. The general condition deteriorated during the procedure or a different intervention was performed with anesthesia,
5. Who wants to leave the study on their own accord.

Primary outcomes:
measure: respiratory rate
timeFrame: 20 minutes of music therapy, white noise and ambient sound before colonoscopy.
Secondary outcomes:
measure: diastolic blood pressure
timeFrame: 20 minutes of music therapy, white noise and ambient sound before colonoscopy.
measure: Visual Analog Scale (VAS)
timeFrame: 20 minutes of music therapy, white noise and ambient sound before a colonoscopy.
measure: The State-Trait Anxiety Inventory (STAI-I)
timeFrame: 20 minutes of music therapy, white noise and ambient sound before colonoscopy.
measure: heart rate
timeFrame: 20 minutes of music therapy, white noise and ambient sound before colonoscopy.
measure: SpO2: peripheral oxygen saturation (%)
timeFrame: 20 minutes of music therapy, white noise and ambient sound before colonoscopy.
measure: systolic blood pressure
timeFrame: 20 minutes of music therapy, white noise and ambient sound before colonoscopy.
Other outcomes:
Locations:
city: Mugla
country: Turkey
facility: Mugla
state: Mentese
city: Muğla
country: Turkey
facility: Mugla
Study officials:
affiliation: Muğla Sıtkı Koçman University
name: Mehtap ÇULLU, PhD
role: PRINCIPAL_INVESTIGATOR
References: