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Acupressure and Training for Coping With PMS

Primary Purpose

Premenstrual Syndrome, Acupressure

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
training +acupressure
training
Sponsored by
Adiyaman University Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premenstrual Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Having regular menstruation (between 21-35 days),

not having any psychiatric diagnosis or any gynecological diseases

not using contraceptives,

not having tissue deformity in the extremities.

Exclusion Criteria:

having any psychiatric diagnosis having any gynecological diseases

Sites / Locations

  • DİDEM
  • ınönü Universty

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

training +acupressure

training

control

Arm Description

In the training+acupressure group, 10 women were excluded from the study since they could not participate in acupressure application at different times, 2 women were excluded since they had menstrual irregularities and 4 women were excluded since they could not be contacted.

In the training group, 4 women were excluded since they did not participate in the reminder training, 1 woman was excluded since she had menstrual irregularities, 3 women were excluded since they wanted to withdraw from the study and 3 women were excluded from the study since they could not be contacted.

In the control group, 4 women were excluded from the study since they could not be reached and 5 women were excluded since they did not agree to participate in the posttest.

Outcomes

Primary Outcome Measures

The Effects of Health Belief Model-Based Training for Coping with Premenstrual Syndrome and Acupressure on Premenstrual Symptoms and Quality of Life
The premenstrual syndrome scale,The lowest score to be taken from the scale is 44 and the highest score is 220. High score shows an increase in the intensity of the symptoms of premenstrual syndrome. If the total scale score is higher than 50% (110) of the highest score (220) in PMS scale, PMS is considered as "present".In the calculation of WHOQOL-BREF scoring, 1st and 2nd items are evaluated independently while the answers obtained from the 3rd, 4th, 26th and 27th questions are reversely scored since they indicate negative statements. The scale does not have a total score. Higher scores obtained from the subscales of the scale indicate that the quality of life level is high.

Secondary Outcome Measures

Full Information

First Posted
March 20, 2019
Last Updated
August 25, 2019
Sponsor
Adiyaman University Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03899207
Brief Title
Acupressure and Training for Coping With PMS
Official Title
Adiyaman University School of Health
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 30, 2017 (Actual)
Primary Completion Date
November 20, 2017 (Actual)
Study Completion Date
April 20, 2018 (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
The study was conducted to determine the effect of acupressure and training, given to women under the guidance of health belief model for coping with premenstrual syndrome, on the premenstrual symptoms and quality of life. This study was conducted to as a randomized controlled trial. The population of the study was composed of all women with PMS registered in FHCs no. 4 and 14 located in the city center. The sample of the study consisted of women including 51 women in training +acupressure group, 55 women in training group and 57 women in control group. The data were collected with Participant Information Form, PMSS and WHOQOL-BREF in the study. Training and acupressure were administered to the acupressure + training group. Only the training for coping with premenstrual syndrome was given to the training group. The data collection forms were reapplied to all groups 12 weeks after the pretest.
Detailed Description
Premenstrual Syndrome is an important collection of symptoms affecting approximately one-fifth of women in reproductive age. Acupressure is an intervention found in the nursing intervention system and defined as applying constant and powerful pressure on certain/specific points of the body in order to reduce pain, provide relaxation and relief, and to prevent or reduce nausea. Many studies conducted in gynecology have shown that acupressure decreased menstrual distress, premenstrual symptoms, back pain in women experiencing dysmenorrhea, labor pain and nausea and vomiting during pregnancy. In addition, it was shown in the studies that training given for PMS decreased the premenstrual symptoms

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome, Acupressure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomize control trail
Masking
Participant
Allocation
Randomized
Enrollment
199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
training +acupressure
Arm Type
Experimental
Arm Description
In the training+acupressure group, 10 women were excluded from the study since they could not participate in acupressure application at different times, 2 women were excluded since they had menstrual irregularities and 4 women were excluded since they could not be contacted.
Arm Title
training
Arm Type
Experimental
Arm Description
In the training group, 4 women were excluded since they did not participate in the reminder training, 1 woman was excluded since she had menstrual irregularities, 3 women were excluded since they wanted to withdraw from the study and 3 women were excluded from the study since they could not be contacted.
Arm Title
control
Arm Type
No Intervention
Arm Description
In the control group, 4 women were excluded from the study since they could not be reached and 5 women were excluded since they did not agree to participate in the posttest.
Intervention Type
Other
Intervention Name(s)
training +acupressure
Intervention Description
.Training+acupressure group; received training for coping with PMS prepared under the guidance of HBM and "The Booklet of Training for Coping with Premenstrual Symptoms" including information about the training given. In addition to the training, acupressure was applied by the researcher twice a week and 24 times in total. Acupressure application was continued with the same frequency until the end of the study (24 times in total for 3 months). One month after the first home visit, reminder training for coping with premenstrual symptoms was given to the women
Intervention Type
Other
Intervention Name(s)
training
Intervention Description
Training Group; received the training for coping with PMS prepared under the guidance of HBM and "The Booklet of Training for Coping with Premenstrual Symptoms" including information about the training given. One month after the first home visit, reminder training was given to the women.
Primary Outcome Measure Information:
Title
The Effects of Health Belief Model-Based Training for Coping with Premenstrual Syndrome and Acupressure on Premenstrual Symptoms and Quality of Life
Description
The premenstrual syndrome scale,The lowest score to be taken from the scale is 44 and the highest score is 220. High score shows an increase in the intensity of the symptoms of premenstrual syndrome. If the total scale score is higher than 50% (110) of the highest score (220) in PMS scale, PMS is considered as "present".In the calculation of WHOQOL-BREF scoring, 1st and 2nd items are evaluated independently while the answers obtained from the 3rd, 4th, 26th and 27th questions are reversely scored since they indicate negative statements. The scale does not have a total score. Higher scores obtained from the subscales of the scale indicate that the quality of life level is high.
Time Frame
10 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having regular menstruation (between 21-35 days), not having any psychiatric diagnosis or any gynecological diseases not using contraceptives, not having tissue deformity in the extremities. Exclusion Criteria: having any psychiatric diagnosis having any gynecological diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didem Simsek Kucukkelepce, phd
Organizational Affiliation
World Health Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
DİDEM
City
Adıyaman
ZIP/Postal Code
02100
Country
Turkey
Facility Name
ınönü Universty
City
Malatya
ZIP/Postal Code
02100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Acupressure and Training for Coping With PMS

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