The Effect of Abdominal Massage and Exercise on Primary Dysmenorrhea in University Students

NCT ID: NCT03821207

Last Updated: 2019-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-06

Study Completion Date

2019-07-02

Brief Summary

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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.

Detailed Description

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The students included in the study will be randomly separated into 3 groups using a computer-based randomisation plan (www.randomization.com).

Those included in the massage 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 from over the abdominal wall to the intestinal area.

The students in the exercise 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.

The control group will perform no exercise or massage. The applications will be demonstrated to the participants by a physiotherapist. Throughout the study period, the students will be followed up to ensure that the applications are being made. Follow-up of the applications of abdominal massage and stretching exercises applied by there searcher physiotherapist according to the study plan will be conducted by the researchers.

The participants will be informed how to apply the massage and perform the exercises and that these applications will cause no side-effects. They will also be informed that participation in the study is voluntary and they can withdraw from the study at any time.

The study will include volunteer female students, aged 18- 20 years, with regular menstrual cycles, who record ≥ 6 points on VAS in the first 3 days of at least 2 of the last 3 menstrual cycles and will not use analgesics during the study.

Data Collection Tools Personal Information Form: This form was prepared by the researchers in accordance with previous reports in literature to include 5 socio-demographic items and 14 items related to the menstrual history (age of menarche, frequency of painful menstruation, amount of bleeding, family history of painful menstruation, methods of dealing with the pain, etc).

Visual Analog Scale (VAS):This scale is a simple method used in the measurement of pain severity and in the follow-up of pain. The patient is instructed to mark the severity of pain on a 10cm horizontal line, where 0= non pain and 10= intolerable pain.

Dysmenorrhea Symptom List:This list was prepared by the researchers in accordance with literature to evaluate the efficacy of the application and includes the findings seen in the presence of dysmenorrhea in females. Each finding is scored from 0-3 as 0= non symptom, 1= mild symptom that does not affect daily activity, 2 = mild non-debilitating symptom that affects daily activity, 3= totally debilitating severe symptom.

Amount of Menstrual Blood: As it is impossible to measure blood lost during menstruation in a laboratory environment, a pictorial blood loss evaluation table will be used,which is a practical and low-cost method with a high accuracy rate. The pictorial blood loss evaluation table was developed to show the degree of soiling. The participants will be given detailed instructions of how to use these forms and will be checked as to whether or not they have understood by being instructed to record a bleeding pattern described by the researchers (eg, mark on the table that in the first 2 days you have used 5 pads completely soiled and in the following 3 days, 2 half pads and 1 with staining). The pictorial index score is calculated by giving points of 1, 5 and 20 to mild, moderately and heavily soiled pads respectively, and scores of 1 and 5 for small and large clots. A cut-off value of 100 will be used. To reduce misinterpretations resulting from the use of different pads, all the participants will be recommended to use the same brand of sanitary pad.

Conditions

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Primary Dysmenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomised Controlled Study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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The exercise group

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

Group Type ACTIVE_COMPARATOR

The exercise group

Intervention Type BEHAVIORAL

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

The abdominal massage group

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

Group Type ACTIVE_COMPARATOR

The abdominal massage group

Intervention Type BEHAVIORAL

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

The control group

The control group will perform no exercise or massage.

Group Type PLACEBO_COMPARATOR

Control Group

Intervention Type BEHAVIORAL

The students will nor massage or exercise

Interventions

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The exercise group

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

Intervention Type BEHAVIORAL

The abdominal massage group

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

Intervention Type BEHAVIORAL

Control Group

The students will nor massage or exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Aydin Adnan Menderes University

OTHER

Sponsor Role lead

Responsible Party

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Meryem Kurek eken

Associated Proffesor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Meryem Kurek Eken

Role: STUDY_DIRECTOR

Aydin Adnan Menderes University

Locations

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Meryem Kurek Eken

Aydin, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 35980872 (View on PubMed)

Other Identifiers

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2018/1357

Identifier Type: -

Identifier Source: org_study_id

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