Primary DysmenorrheaNCT05158036
Comparison of the Effects of Different Massage Techniques in Women With Primary Dysmenorrhea
A study testing Classic massage group and Connective tissue masage in people with Primary Dysmenorrhea, run by Ataturk Training and Research Hospital.
Trial summary
The aim of this study was to compare the effects of different massage techniques on pain, primary dysmenorrhea (PD)-related symptoms and functional and emotional influence in women with PD. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Classic massage group and Connective tissue masage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2021to Dec 2022
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years of age
- Women with a complaint of primary dysmenorrhea,
- Volunteer women who have a regular menstrual cycle (28 ± 7 days)
- Women who have menstrual pain intensity greater than 40 mm according to the Visual Analogue Scale considering the last 6 months
Who cannot join
- Having gastrointestinal, urogynecological, autoimmune, psychiatric diseases and/or other chronic pain syndromes,
- Those who have given birth,
- Those who have a pregnancy status,
- Those who use intrauterine devices,
- Those who have had pelvic surgery,
- Those who use chronic medications, including oral contraceptives or antidepressants, for at least 6 months before the study,
- Those with a pathological history and radiological findings showing secondary dysmenorrhea
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study was to compare the effects of different massage techniques on pain, primary dysmenorrhea (PD)-related symptoms and functional and emotional influence in women with PD.
Read the detailed description
Primary dysmenorrhea is defined as painful menstrual cramps without an underlying pelvic pathology or organic problem. Massage, which is one of the physiotherapy methods that reduces pain by acting on the autonomic nervous system and circulation, has an important place in the management of PD among non-pharmacological treatment approaches. In the literature, there are studies on the use of classical massage and connective tissue massage in women with PD for reducing menstrual pain and PD-related symptoms. However, to the best of our knowledge, no study has been found comparing classical massage and connective tissue massage in PD management.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Classic massage group, Connective tissue masage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classic massage groupOther
Classic massage application will be given to the Classic massage group
Connective tissue masageOther
Connective tissue masage application will be given to the Connective tissue masage group
| Study group | Role | What they receive |
|---|---|---|
| Classic massage group | Active comparator | Classical massage will be applied to the lumbal and abdominal region 5 days a week, from the estimated date of ovulation until the next menstrual bleeding begins. The application will take approximately 15 minutes. During the massage, the physiotherapist will apply stroking and kneading movements by using baby oil. During the treatment of the lumbal region, the patient will be in the prone position; during the treatment of the abdominal region, the patient will be in the supine position. Receives: Other: Classic massage group |
| Connective tissue massage group | Active comparator | Connective tissue massage will be applied to the lumbosacral, lower thoracic, abdominal and anterior pelvic regions 5 days a week, from the estimated date of ovulation until the onset of the next menstrual bleeding. The application will take approximately 15 minutes. During the massage, the physiotherapist will bring the tip of the middle finger of the hand into contact with the patient's skin and apply traction to the skin. During the treatment of the lumbar region, the patient will be in the sitting position, during the treatment of the abdominal and anterior pelvic region, the patient will be in the supine position. Receives: Other: Connective tissue masage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Menstrual pain intensity will be evaluated with Visual Analogue Scale.
Measured: change from baseline at an average of 2 weeks
Secondary outcomes (3)
Pressure pain threshold
Pressure pain threshold will be evaluated with algometer
Measured: change from baseline at an average of 2 weeks
Primary dysmenorrhea (PD)-related symptoms
Severity of PD-related symptoms will be evaluated Visual Analogue Scale.
Measured: change from baseline at an average of 2 weeks
Functional and emotional effects
Functional and emotional effects will be evaluated with Functional and Emotional Dysmenorrhea Scale.
Measured: change from baseline at an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study startDec 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- Participants will be randomly divided into two groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyda TOPRAK CELENAY, Ataturk Training and Research Hospital
- Investigators
- Seyda Toprak Celenay, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158036
- Sponsor's protocol ID
- 2021/12/01
- Status last verified
- Dec 2021
- First submitted
- 2 Dec 2021
- Last updated
- 15 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Different Massage Techniques in Women With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT05158036
- Acronym / sponsor ID
- 2021/12/01
- Conditions
- Primary Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ataturk Training and Research HospitalUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 15 Dec 2021 (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 aim of this study was to compare the effects of different massage techniques on pain, primary dysmenorrhea (PD)-related symptoms and functional and emotional influence in women with PD.
Detailed description
Primary dysmenorrhea is defined as painful menstrual cramps without an underlying pelvic pathology or organic problem. Massage, which is one of the physiotherapy methods that reduces pain by acting on the autonomic nervous system and circulation, has an important place in the management of PD among non-pharmacological treatment approaches. In the literature, there are studies on the use of classical massage and connective tissue massage in women with PD for reducing menstrual pain and PD-related symptoms. However, to the best of our knowledge, no study has been found comparing classical massage and connective tissue massage in PD management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly divided into two groups
| Arm | Type | Receives |
|---|---|---|
| Classic massage group | Active comparator | Other: Classic massage groupClassical massage will be applied to the lumbal and abdominal region 5 days a week, from the estimated date of ovulation until the next menstrual bleeding begins. The application will take approximately 15 minutes. During the massage, the physiotherapist will apply stroking and kneading movements by using baby oil. During the treatment of the lumbal region, the patient will be in the prone position; during the treatment of the abdominal region, the patient will be in the supine position. |
| Connective tissue massage group | Active comparator | Other: Connective tissue masageConnective tissue massage will be applied to the lumbosacral, lower thoracic, abdominal and anterior pelvic regions 5 days a week, from the estimated date of ovulation until the onset of the next menstrual bleeding. The application will take approximately 15 minutes. During the massage, the physiotherapist will bring the tip of the middle finger of the hand into contact with the patient's skin and apply traction to the skin. During the treatment of the lumbar region, the patient will be in the sitting position, during the treatment of the abdominal and anterior pelvic region, the patient will be in the supine position. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years of age
- Women with a complaint of primary dysmenorrhea,
- Volunteer women who have a regular menstrual cycle (28 ± 7 days)
- Women who have menstrual pain intensity greater than 40 mm according to the Visual Analogue Scale considering the last 6 months
Key exclusion criteria (7 listed)
- Having gastrointestinal, urogynecological, autoimmune, psychiatric diseases and/or other chronic pain syndromes,
- Those who have given birth,
- Those who have a pregnancy status,
- Those who use intrauterine devices,
- Those who have had pelvic surgery,
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 |
|---|---|---|
| Classic massage groupClassic massage application will be given to the Classic massage group | Other | Classic massage group |
| Connective tissue masageConnective tissue masage application will be given to the Connective tissue masage group | Other | Connective tissue massage group |
Primary outcome
Pain intensity
Time frame: change from baseline at an average of 2 weeks
Menstrual pain intensity will be evaluated with Visual Analogue Scale.
3 secondary outcomes
Pressure pain threshold
Time frame: change from baseline at an average of 2 weeks
Primary dysmenorrhea (PD)-related symptoms
Time frame: change from baseline at an average of 2 weeks
Functional and emotional effects
Time frame: change from baseline at an average of 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
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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.
Seyda Toprak Celenay principal investigator
Ankara Yildirim Beyazıt University
Questions about this trial
What is this clinical trial studying?
A study testing Classic massage group and Connective tissue masage in people with Primary Dysmenorrhea, run by Ataturk Training and Research Hospital.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seyda Toprak Celenay (+90312 906 1000, sydtoprak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: change from baseline at an average of 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2021.