NCT06659133

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2024

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 26, 2024

Completed
Last Updated

October 26, 2024

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

October 22, 2024

Last Update Submit

October 23, 2024

Conditions

Keywords

painanxiety

Outcome Measures

Primary Outcomes (1)

  • anxiety

    State and Trait Anxiety Scale

    30 min

Study Arms (2)

Control

NO INTERVENTION

control group received routine care during pipelined endometrial biopsy.

Music

EXPERIMENTAL

The experimental group listened to acemashiran maqam music during pipelined endometrial biopsy.

Other: Music intervention

Interventions

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

Music

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Didem Simsek Kucukkelepce

Adıyaman, 02100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd

Study Record Dates

First Submitted

October 22, 2024

First Posted

October 26, 2024

Study Start

December 13, 2023

Primary Completion

April 20, 2024

Study Completion

May 14, 2024

Last Updated

October 26, 2024

Record last verified: 2024-10

Locations