NCT03821207

Brief Summary

The study will planing to determine the advantages of abdominal massage and exercise on primary dysmenorrhea in university students, and to evaluate whether one of these applications is superior to the other.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 6, 2018

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

December 30, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 29, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2019

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2019

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

6 months

First QC Date

December 30, 2018

Last Update Submit

July 3, 2019

Conditions

Primary Dysmenorrhea

Keywords

Abdominal massageExercisePrimary Dysmenorrhea

Outcome Measures

Primary Outcomes (2)

  • The primer outcome of the study was to investigate the effects of abdominal massage and exercise on the level of pain

    Visuale Analogue Scale will be used to measure pain level at 3 menstrual cycle. The change from baseline in Visual Analog Scale at 3 menstrual cycle will be measured in the studied groups

    6 month

  • The other primer outcome of the study was to investigate the effects of abdominal massage and exercise duration of pain.

    Dysmenorrhea Symptom List will be used to measure degree of dysmenorrhea symptoms at 3 menstrual cycle. The findings seen in the presence of dysmenorrhea in females during 3 menstrual cycle will be measured by decrease at severity of scores belong to Dysmenorrhea Symptom List.

    6 month

Secondary Outcomes (1)

  • The seconder outcome of the study was to investigate the effects of abdominal massage and exercise amount of menstruel bleeding

    6 month

Study Arms (3)

The exercise group

ACTIVE COMPARATOR

The group will be instructed to perform stretching exercises including the pelvic and lumbar regions 3 times a day for the first 3 days of the menstrual cycle

Behavioral: The exercise group

The abdominal massage group

ACTIVE COMPARATOR

The group will be instructed to massage the abdomen for 10 mins a day on the first 3 days of the menstrual cycle.The massage is to be applied as effleurage (light touch) clockwise over the abdomen

Behavioral: The abdominal massage group

The control group

PLACEBO COMPARATOR

The control group will perform no exercise or massage.

Behavioral: Control Group

Interventions

The exercise groupBEHAVIORAL

The students will make exercise during the first three days of the menstrual period

The exercise group
The abdominal massage groupBEHAVIORAL

The students will make abdominal massage during the first three days of the menstrual period

The abdominal massage group
Control GroupBEHAVIORAL

The students will nor massage or exercise

The control group

Eligibility Criteria

Age18 Years - 20 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Regular menstrual cycles Record ≥ 6 points on VAS in the first 3 days of at least 2 of the last 3 menstrual cycles Not use analgesics during the study period

You may not qualify if:

  • Endometriosis Pelvic inflammatory disease Ovarian cyst Myoma Chronic pelvic pain Urinary system infection Menometrorrhagia Obstructive vaginal or uterine congenital anomalies Secondary dysmenorrhea A history of major abdominal or pelvic surgery in the last 3 months Hormonal treatment in the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meryem Kurek Eken

Aydin, 09013, Turkey (Türkiye)

Location

Related Publications (1)

  • Ozturk N, Gercek Oter E, Kurek Eken M. The effect of abdominal massage and stretching exercise on pain and dysmenorrhea symptoms in female university students: A single-blind randomized-controlled clinical trial. Health Care Women Int. 2023 May;44(5):621-638. doi: 10.1080/07399332.2022.2061973. Epub 2022 Aug 18.

    PMID: 35980872DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Meryem Kurek Eken

    Aydin Adnan Menderes University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Randomised Controlled Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Proffesor

Study Record Dates

First Submitted

December 30, 2018

First Posted

January 29, 2019

Study Start

December 6, 2018

Primary Completion

June 6, 2019

Study Completion

July 2, 2019

Last Updated

July 5, 2019

Record last verified: 2019-07

Locations

TU(1)