NCT03899207

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
199

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

June 30, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

5 months

First QC Date

March 20, 2019

Last Update Submit

August 25, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 month

Study Arms (3)

training +acupressure

EXPERIMENTAL

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

EXPERIMENTAL

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

control

NO INTERVENTION

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.

Interventions

.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

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.

training +acupressure

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • having any psychiatric diagnosis having any gynecological diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

DİDEM

Adıyaman, 02100, Turkey (Türkiye)

Location

ınönü Universty

Malatya, 02100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Didem Simsek Kucukkelepce, phd

    World Health Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomize control trail
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adiyaman Universty

Study Record Dates

First Submitted

March 20, 2019

First Posted

April 2, 2019

Study Start

June 30, 2017

Primary Completion

November 20, 2017

Study Completion

April 20, 2018

Last Updated

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations