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Completed

NCT Number: NCT06659133

Effect of Music On Pain and Anxiety Paddle Edometrial Biopsy

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Didem Simsek Kucukkelepce

Adıyaman, 02100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Music intervention

Other

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

Primary outcomes

  1. anxiety

    Time frame: 30 min

    State and Trait Anxiety Scale

Sponsors and collaborators

Lead sponsor

Adiyaman University Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 26, 2024
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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