Effects of Music Therapy and White Noise on Pre-procedural Fear, Anxiety by Elderly Colonoscopy Patients

NCT06669338 | Completed

• 1 other identifier: MuglaSKU-HEM-MC-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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

Conditions

Colonoscopy; the Elderly; White Noise; Music Therapy; Fear; Anxiety

Keywords

Colonoscopy;anxiety;fear;vital signs;musictherapy;whitenoise

Outcome Measures

Primary Outcomes (1)

• respiratory rate

  Measurements are made at the beginning and end of the music therapy, white noise and ambient sound listening intervention before colonoscopy.

  20 minutes of music therapy, white noise and ambient sound before colonoscopy.

Secondary Outcomes (6)

• diastolic blood pressure

  20 minutes of music therapy, white noise and ambient sound before colonoscopy.

• Visual Analog Scale (VAS)

  20 minutes of music therapy, white noise and ambient sound before a colonoscopy.

• The State-Trait Anxiety Inventory (STAI-I)

  20 minutes of music therapy, white noise and ambient sound before colonoscopy.

• heart rate

  20 minutes of music therapy, white noise and ambient sound before colonoscopy.

• SpO2: peripheral oxygen saturation (%)

  20 minutes of music therapy, white noise and ambient sound before colonoscopy.

Study Arms (3)

music therapy group

EXPERIMENTAL

The group that listened to music for 20 minutes before the colonoscopy

Other: Music therapy

white noise group

EXPERIMENTAL

The group that listened to white noise for 20 minutes before the colonoscopy

Other: listen to white noise

control group

PLACEBO COMPARATOR

The group that listened to recorded ambient sound for 20 minutes before the colonoscopy.

Other: listen to hospital ambient sound

Interventions

Music therapy OTHER

patients listen to music for 20 minutes with headphones before colonoscopy.

music therapy group

listen to white noise OTHER

patients listen to white noise with headphones for 20 minutes before colonoscopy.

white noise group

listen to hospital ambient sound OTHER

patients listen to recorded ambient sound for 20 minutes with headphones before colonoscopy.

control group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (2)

Mugla

Muğla, Mentese, 48000, Turkey (Türkiye)

Location

Mugla

Muğla, 48000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Mehtap ÇULLU, PhD

  Muğla Sıtkı Koçman University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: results evaluator
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd lecturer

Model Details: experimental study with three groups.

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: November 1, 2024
• Study Start: October 25, 2024
• Primary Completion: November 25, 2024
• Study Completion: November 25, 2024
• Last Updated: December 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)