- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04356820
The Effect of Music Played and Acupressure Application on Pain and Anxiety in Women Undergoing Gynecological Examination
April 20, 2020 updated by: Didem Kucukkelepce, Adiyaman University Research Hospital
This study was carried out to determine the effect of listening to music and acupressure application in reducing pain and anxiety during gynecological examination.
Study Overview
Study Type
Interventional
Enrollment (Actual)
156
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Adıyaman, Turkey, 02100
- Didem Simsek Kucukkelepce
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- - 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
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control
|
|
|
Experimental: acupressure
|
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
Other Names:
|
|
Experimental: music
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
questionnaire and scale
Time Frame: 12 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2019
Primary Completion (Actual)
July 15, 2019
Study Completion (Actual)
September 10, 2019
Study Registration Dates
First Submitted
April 16, 2020
First Submitted That Met QC Criteria
April 20, 2020
First Posted (Actual)
April 22, 2020
Study Record Updates
Last Update Posted (Actual)
April 22, 2020
Last Update Submitted That Met QC Criteria
April 20, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Adıyaman_Universty
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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