Back to resultsThe Effect of Music Played and Acupressure Application on Pain and Anxiety in Women Undergoing Gynecological Examination
Primary Purpose
Pain, Acute, Anxiety Acute
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
acupressure
Sponsored by
About this trial
This is an interventional supportive care trial for Pain, Acute focused on measuring acupressure,, nursing, music, gynecological examination
Eligibility Criteria
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:
-
Sites / Locations
- Didem Simsek Kucukkelepce
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
acupressure
music
control
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04356820
First Posted
April 16, 2020
Last Updated
April 20, 2020
Sponsor
Adiyaman University Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04356820
Brief Title
The Effect of Music Played and Acupressure Application on Pain and Anxiety in Women Undergoing Gynecological Examination
Official Title
The Effect of Music Played and Acupressure Application on Pain and Anxiety in Women Undergoing Gynecological Examination
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
July 15, 2019 (Actual)
Study Completion Date
September 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Adiyaman University Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Anxiety Acute
Keywords
acupressure,, nursing, music, gynecological examination
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
randomized
Masking
Participant
Allocation
Randomized
Enrollment
156 (Actual)
8. Arms, Groups, and Interventions
Arm Title
acupressure
Arm Type
Experimental
Arm Title
music
Arm Type
Experimental
Arm Title
control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
acupressure
Other Intervention Name(s)
music
Intervention Description
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
Primary Outcome Measure Information:
Title
questionnaire and scale
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
-
Facility Information:
Facility Name
Didem Simsek Kucukkelepce
City
Adıyaman
ZIP/Postal Code
02100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Music Played and Acupressure Application on Pain and Anxiety in Women Undergoing Gynecological Examination
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