Primary DysmenorrheaNCT03821207
The Effect of Abdominal Massage and Exercise on Primary Dysmenorrhea in University Students
A study testing The exercise group and The abdominal massage group in people with Primary Dysmenorrhea, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 20 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- The exercise group and The abdominal massage group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Dec 2018to 2 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 20 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Abdominal Massage and Exercise on Primary Dysmenorrhea in University Students: A Randomised Controlled Study
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.
Read the 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.
- Conditions
- Primary Dysmenorrhea
- Being tested
- The exercise group, The abdominal massage group, Control Group
- Keywords
- Abdominal massage, Exercise, Primary Dysmenorrhea
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The exercise groupBehavioural
The students will make exercise during the first three days of the menstrual period
The abdominal massage groupBehavioural
The students will make abdominal massage during the first three days of the menstrual period
Control GroupBehavioural
The students will nor massage or exercise
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: The abdominal massage group |
| The control group | Placebo comparator | The control group will perform no exercise or massage. Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
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
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start6 Dec 2018
- Primary completion6 Jun 2019
- Study completion2 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised Controlled Study
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meryem Kurek eken, Aydin Adnan Menderes University
- Investigators
- Meryem Kurek Eken, Study director, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03821207
- Sponsor's protocol ID
- 2018/1357
- Status last verified
- Jul 2019
- First submitted
- 30 Dec 2018
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35980872
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Abdominal Massage and Exercise on Primary Dysmenorrhea in University Students: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT03821207
- Acronym / sponsor ID
- 2018/1357
- Conditions
- Primary Dysmenorrhea
- Keywords
- Abdominal massage, Exercise, Primary Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 6 Jun 2019 (actual)
- Study completion
- 2 Jul 2019 (actual)
- First posted
- 29 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomised Controlled Study
| Arm | Type | Receives |
|---|---|---|
| The exercise group | Active comparator | Behavioral: The exercise groupThe 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 abdominal massage group | Active comparator | Behavioral: The abdominal massage groupThe 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 |
| The control group | Placebo comparator | Behavioral: Control GroupThe control group will perform no exercise or massage. |
Who may qualify
- Ages
- 18 to 20 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The exercise groupThe students will make exercise during the first three days of the menstrual period | Behavioural | The exercise group |
| The abdominal massage groupThe students will make abdominal massage during the first three days of the menstrual period | Behavioural | The abdominal massage group |
| Control GroupThe students will nor massage or exercise | Behavioural | The control group |
Primary outcome
The primer outcome of the study was to investigate the effects of abdominal massage and exercise on the level of pain
Time frame: 6 month
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
The other primer outcome of the study was to investigate the effects of abdominal massage and exercise duration of pain.
Time frame: 6 month
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.
1 secondary outcome
The seconder outcome of the study was to investigate the effects of abdominal massage and exercise amount of menstruel bleeding
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Derived from this study: PubMed 35980872Ozturk 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meryem Kurek Eken study director
Aydin Adnan Menderes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The exercise group and The abdominal massage group in people with Primary Dysmenorrhea, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primer outcome of the study was to investigate the effects of abdominal massage and exercise on the level of pain (time frame: 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03821207, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.