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

Primary Dysmenorrhea Clinical Trial

Official title:

The Effect of Abdominal Massage and Exercise on Primary Dysmenorrhea in University Students: A Randomised Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03821207
• Other study ID #: 2018/1357
• Status: Completed
• Phase: N/A
• Start date: December 6, 2018
• Est. completion date: July 2, 2019

Study information

• Verified date: July 2019
• Source: Aydin Adnan Menderes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2, 2019
• Est. primary completion date: June 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

Behavioral:
• The exercise group
The students will make exercise during the first three days of the menstrual period
• The abdominal massage group
The students will make abdominal massage during the first three days of the menstrual period
• Control Group
The students will nor massage or exercise

Locations

Country	Name	City	State
Turkey	Meryem Kurek Eken	Aydin

Sponsors (1)

Lead Sponsor	Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	The seconder outcome of the study was to investigate the effects of abdominal massage and exercise amount of menstruel bleeding	Pictorial Blood Loss Evaluation Table will be used to measure the amount of menstrual bleeding. The amount of menstrual bleeding will be measured by change from baseline in the pictorial index score at 3 menstrual cycle	6 month