NCT04356820

Brief Summary

This study was carried out to determine the effect of listening to music and acupressure application in reducing pain and anxiety during gynecological examination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 22, 2020

Completed
Last Updated

April 22, 2020

Status Verified

April 1, 2020

Enrollment Period

3 months

First QC Date

April 16, 2020

Last Update Submit

April 20, 2020

Conditions

Keywords

acupressure,nursingmusicgynecological examination

Outcome Measures

Primary Outcomes (1)

  • questionnaire and scale

    McGill pain scale was developed by Melzack in 1987 and its validity and reliability in Turkish Yakut et al. (2007). In this study, the Short Form-McGill Pain Questionnaire (KF-MAA), whose validity and reliability was used and frequently used by Biçici (2010), was applied. This questionnaire consists of a total of 15 descriptive words to determine the sensory (11 words) and affective (4 words) dimensions of pain. In this section, the severity of pain (0 = none, 1 = mild, 2 = moderate, 3 = severe) is evaluated and three pain scores (sensory, affective and total pain rate = sensory affective) are obtained. In addition, the pain felt at the time of measurement is measured with the Visuel Analog Scale (VAS) and the total pain intensity is measured with a 6-point Likert scale. On this scale, 0 = no pain, 1 = mild, 2 = disturbing, 3 = distressing, 4 = terrible, 5 = unbearable pain.

    12 weeks

Study Arms (3)

acupressure

EXPERIMENTAL
Other: acupressure

music

EXPERIMENTAL
Other: acupressure

control

NO INTERVENTION

Interventions

Data collection took about 10 to 15 minutes. Then the woman invited to the examination room was asked to pull one of the envelopes with the names of the groups. The women who pulled the acupressure envelope were given a semi-sitting position where the acupressure application can feel comfortable and the researcher can easily apply the acupressure points. Before the acupressure application, massage was applied for 30 seconds to ensure circulation. Afterwards, 90 seconds consecutive pressures were applied to the specified acupressure points in a certain order (SP 6, Li 4), taking into account the direction of the meridian. After the examination, the pain formed during the gynecological examination was evaluated by applying the Short Form-McGill Pain Questionnaire without leaving the examination room

Also known as: music
acupressuremusic

Eligibility Criteria

Age19 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- not to be pregnant,
  • no hearing problems
  • Being between the ages of 19 and 65, Not having any psychiatric illness,
  • No gynecological cancer, Not to have any deformity in her extremities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Didem Simsek Kucukkelepce

Adıyaman, 02100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Pain

Interventions

AcupressureMusic Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationSensory Art TherapiesAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

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

Study Record Dates

First Submitted

April 16, 2020

First Posted

April 22, 2020

Study Start

May 1, 2019

Primary Completion

July 15, 2019

Study Completion

September 10, 2019

Last Updated

April 22, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations