CClinicalTrials.gg
CompletedNCT06659133Updated Oct 26, 2024

Effect of Music On Pain and Anxiety Paddle Edometrial Biopsy

An interventional study of Music intervention in Gynecologic Nursing, sponsored by Adiyaman University Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-26.

Sponsored by Adiyaman University Research Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Dec 2023, registered Oct 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Gynecologic Nursing

Keywords

  • pain
  • anxiety
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In context

Lead sponsor

Adiyaman University Research Hospital is the lead sponsor of 48 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.

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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
64 participants (actual)

Study arms

  • 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

Interventions

  • OtherMusic 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

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What researchers measure

Primary outcomes

  1. anxiety

    State and Trait Anxiety Scale

    Time frame: 30 min

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Study locations

1 site
  • Didem Simsek Kucukkelepce
    Adiyaman, 02100, Turkey
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06659133
Lead sponsor
Adiyaman University Research Hospital
Responsible party
Didem Kucukkelepce (Phd, Lokman Hekim Üniversitesi) — Principal investigator
First posted
Oct 26, 2024
Start date
Dec 13, 2023
Primary completion
Apr 20, 2024
Completion
May 14, 2024
Last update
Oct 26, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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