Effects of Music Therapy on Procedural Pain, Anxiety and Comfort Level During Cystoscopy

NCT04413175 | Completed

• 1 other identifier: HanifeD
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Aims and objectives: This study aimed to determine the effect of music therapy on procedural pain intensity and anxiety and comfort levels in patients during cystoscopy. Background: Cystoscopy is a procedure that is commonly performed as day surgery in urology clinics in order to diagnose lower urinary tract system symptoms as well as to diagnose and follow up tumors associated with the lower urinary system. During cystoscopy, which is an invasive intervention, individuals may experience pain and anxiety, and their comfort may be negatively affected. Methods: This study was a prospective, randomized controlled trial. Study participants were randomly assigned to either a control or music group. The outcome measures were assessed using the Visual Analogue Scale, State Anxiety Scale, and General Comfort Questionnaire. This report followed the CONSORT checklist.

Conditions

Cystoscopy

Keywords

Anxiety; comfort; cystoscopy; music therapy; pain

Outcome Measures

Primary Outcomes (7)

• Pain scores

  The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain

  before cystoscopy

• Pain scores

  The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain

  during cystoscopy procedure

• Pain scores

  The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain

  immediately after cystoscopy procedure is completed

• Anxiety score

  Anxiety was used as the secondary outcome and measured using the Turkish version of the State-Trait Anxiety Inventory (STAI). The inventory was developed by Spielberger and colleagues and tested for its validity and reliability in Turkish by Öner and Le Compte. Its internal consistency, test-retest reliability, and item-by-item reliability values were found to be between 0.83 and 0.87, 0.71 and 0.86, and 0.34 and 0.72, respectively. The STAI consists of a State Anxiety Scale (STAI-S) and a Trait Anxiety Scale (STAI-T). Only the STAI-S was used in this study. The lowest total score that can be obtained from the scale is 20, and the highest total score is 80. A high score indicates high anxiety level, and a low score indicates low anxiety level

  before cystoscopy

• Anxiety score

  Anxiety was used as the secondary outcome and measured using the Turkish version of the State-Trait Anxiety Inventory (STAI). The inventory was developed by Spielberger and colleagues and tested for its validity and reliability in Turkish by Öner and Le Compte. Its internal consistency, test-retest reliability, and item-by-item reliability values were found to be between 0.83 and 0.87, 0.71 and 0.86, and 0.34 and 0.72, respectively. The STAI consists of a State Anxiety Scale (STAI-S) and a Trait Anxiety Scale (STAI-T). Only the STAI-S was used in this study. The lowest total score that can be obtained from the scale is 20, and the highest total score is 80. A high score indicates high anxiety level, and a low score indicates low anxiety level

  immediately after cystoscopy procedure is completed

• Comfort scores

  The third outcome was comfort, which was measured using the General Comfort Questionnaire (GCQ). This questionnaire was developed by Katharine Kolcaba to determine individuals' comfort needs and evaluate nursing interventions that may be employed to ensure and increase such comfort. The GCQ uses a four-point Likert-type scale and consists of 48 items. The lowest score that can be obtained when using the scale is 48, and the highest score is 192. The GCQ was adapted for use in a Turkish context by Kuğuoğlu and Karabacak.

  before cystoscopy

• Comfort scores

  The third outcome was comfort, which was measured using the General Comfort Questionnaire (GCQ). This questionnaire was developed by Katharine Kolcaba to determine individuals' comfort needs and evaluate nursing interventions that may be employed to ensure and increase such comfort. The GCQ uses a four-point Likert-type scale and consists of 48 items. The lowest score that can be obtained when using the scale is 48, and the highest score is 192. The GCQ was adapted for use in a Turkish context by Kuğuoğlu and Karabacak.

  immediately after cystoscopy procedure is completed

Study Arms (2)

a music group

EXPERIMENTAL

Patients in the music group were provided music therapy that was prepared by the Turkish Psychological Association. They listened to the music that has a calming and relaxing effect for 20 min before and during the procedure.

Other: music therapy

control group

NO INTERVENTION

control group

Interventions

music therapy OTHER

Patients in the music group were provided music therapy that was prepared by the Turkish Psychological Association. They listened to the music that has a calming and relaxing effect for 20 min before and during the procedure. A portable MP3 player connected to double earphones was used in the present study. After patients took the lithotomy position for cystoscopy, their headphones were inserted and music began to be played. Music was played to the individuals for 20 minutes before and during the procedure. Headphones were removed immediately after the procedure was completed and the double earphones were cleaned with antiseptic solution after each application.

a music group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years,
• Being literate,
• Having no hearing problems.

You may not qualify if:

• Patients who had allergies to anesthetic drugs
• Urinary tract infection.

Sponsors & Collaborators

• Ordu University: lead

Study Sites (1)

Giresun University

Giresun, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Hanife Durgun, Dr

  Ordu State Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: June 2, 2020
• Study Start: April 1, 2019
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: June 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)