Acupressure and Training for Coping With PMS

Sponsor

Adiyaman University Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03899207

Collaborator

(none)

199

Enrollment

Locations

Arms

9.7

Actual Duration (Months)

99.5

Patients Per Site

10.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Premenstrual Syndrome Acupressure	Other: training +acupressure Other: training	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

199 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomize control trailrandomize control trail

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

Adiyaman University School of Health

Actual Study Start Date :

Jun 30, 2017

Actual Primary Completion Date :

Nov 20, 2017

Actual Study Completion Date :

Apr 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: training +acupressure 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.	Other: training 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.
Experimental: training 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.	Other: training +acupressure .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
No Intervention: control 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.

Arm

Intervention/Treatment

Experimental: training +acupressure

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.

Other: training

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.

Experimental: training

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.

Other: training +acupressure

.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

No Intervention: control

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.

Outcome Measures

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 [10 month]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	DİDEM	Adıyaman		Turkey	02100
2	ınönü Universty	Malatya		Turkey	02100

Sponsors and Collaborators

Adiyaman University Research Hospital

Investigators

Principal Investigator: Didem Simsek Kucukkelepce, phd, World Health Organization

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Didem Kucukkelepce, Adiyaman Universty, Adiyaman University Research Hospital

ClinicalTrials.gov Identifier:

NCT03899207

Other Study ID Numbers:

Adiyaman Universty

First Posted:

Apr 2, 2019

Last Update Posted:

Aug 28, 2019

Last Verified:

Aug 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Premenstrual Syndrome

Study Results

No Results Posted as of Aug 28, 2019