Clinical trial NCT03821207: The Effect of Abdominal Massage and Exercise on Primary Dysmenorrhea in University Students
Official title: The Effect of Abdominal Massage and Exercise on Primary Dysmenorrhea in University Students: A Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dysmenorrhea
Keywords: Abdominal massage
Exercise
Primary Dysmenorrhea
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 20
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised Controlled Study
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The primer outcome of the study was to investigate the effects of abdominal massage and exercise on the level of pain
timeFrame: 6 month
measure: The other primer outcome of the study was to investigate the effects of abdominal massage and exercise duration of pain.
timeFrame: 6 month
Secondary outcomes:
measure: The seconder outcome of the study was to investigate the effects of abdominal massage and exercise amount of menstruel bleeding
timeFrame: 6 month
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Meryem Kurek Eken
Study officials:
affiliation: Aydin Adnan Menderes University
name: Meryem Kurek Eken
role: STUDY_DIRECTOR
References: