Effect of Music On Pain and Anxiety Paddle Edometrial Biopsy

In Women Undergoıng Paddle Endometrıal Bıopsy Applıed Musıc Recıtal Effect On Paın And Anxıety

This study was conducted as a randomized controlled trial to investigate the effect of music recital on pain and anxiety in women undergoing pipelined endometrial biopsy.

Study Overview

• Status: Completed
• Conditions: Gynecologic Nursing
• Intervention / Treatment: Other: Music intervention

Detailed Description

This study was conducted as a randomized controlled trial to investigate the effect of music recital on pain and anxiety in women undergoing pipelined endometrial biopsy. The data were collected in the intervention room of the mixed service of a state hospital in Ankara between December 2023 and April 2024. Power analysis was performed with the G*Power 3.1 program to determine the number of people to be included in the study. The study was conducted with a total of 64 women, 32 in the control group and 32 in the experimental group. The data were collected using the Personal Information Form, "Visual Comparison Scale" to assess the severity of pain, and "State and Trait Anxiety Scale" to determine the level of anxiety. The experimental group listened to acemashiran maqam music, while the control group received routine care. There was no significant difference between the control and experimental groups in the distribution of socio-demographic characteristics.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Adiyaman, Turkey, 02100
    • Didem Simsek Kucukkelepce

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Women aged 18 and over who underwent endometrial biopsy for the first time

Exclusion Criteria:

Those who did not fill out the consent form, Those who were illiterate, Those who were receiving inpatient treatment during the study, Those with psychiatric illness (dementia, psychosis, etc.), Those who were on regular medication (such as analgesics, anxiolytics or sedatives), Those who had communication problems (vision, hearing and perception problems), Women who were in pain before the procedure were not included.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; control group received routine care during pipelined endometrial biopsy.
Experimental: Music; The experimental group listened to acemashiran maqam music during pipelined endometrial biopsy.	Other: Music intervention; The women participating in the study were divided into control and experimental groups. The control group included women who underwent pipelle endometrial biopsy with routine care, and the experimental group included women who underwent pipelle endometrial biopsy accompanied by music. Pipelle endometrial biopsy was performed by the same physician working in the Department of Obstetrics and Gynecology at the hospital. Patients in both groups were interviewed 10 minutes before the endometrial biopsy procedure and the Personal Information Form and State and Trait Anxiety Scale were applied. The application of the GKO was explained to the patients before the pipelle endometrial biopsy procedure. Before the pipelle endometrial biopsy, all patients were routinely given local anesthesia with 8 cc of 2% lidocaine solution and waited for 5 minutes after the application of local anesthesia. During the pipelle endometrial biopsy, the experimental group was given a music recital from an mp3 play

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anxiety	State and Trait Anxiety Scale	30 min

Collaborators and Investigators

• Sponsor: Adiyaman University Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2023
• Primary Completion (Actual): April 20, 2024
• Study Completion (Actual): May 14, 2024

Study Registration Dates

• First Submitted: October 22, 2024
• First Submitted That Met QC Criteria: October 23, 2024
• First Posted (Actual): October 26, 2024

Study Record Updates

• Last Update Posted (Actual): October 26, 2024
• Last Update Submitted That Met QC Criteria: October 23, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: pain; anxiety
• Other Study ID Numbers: lokmanhekim universty

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No