Primary DysmenorrheaNCT05328869
The Effects Of Relaxation Training In Women With Primary Dysmenorrhea
A study testing Relaxation training in people with Primary Dysmenorrhea, run by Ankara Yildirim Beyazıt University.
Trial summary
The aim of this study was to investigate the effects of relaxation training on menstrual pain severity, menstrual symptoms, impact of quality of life, impact of work/academic performance, impact of social activity level and anxiety level in women with primary dysmenorrhea (PD) complaints. 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?
- Relaxation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2022to 15 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
- Women with primary dysmenorrhea complaint according to the Primary Dysmenorrhea Consensus Guide,
- Over 18 years of age,
- Having a mean pain intensity of moderate and higher according to the Visual Analogue Scale in the last 6 months,
- Having a regular menstrual cycle (28±7 days),
- Volunteered to participate in the study.
Who cannot join
- Having a pathological history and radiological findings pointing to secondary dysmenorrhea,
- Using oral contraceptives/antidepressants at least 6 months,
- Receiving hormone therapy,
- Undergoing pelvic surgery,
- Pregnant,
- Giving birth,
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- Using an intrauterine device,
- Having neurological, orthopedic and/or rheumatological diseases
- Having a psychiatric disease,
- Having a history of malignancy
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study was to investigate the effects of relaxation training on menstrual pain severity, menstrual symptoms, impact of quality of life, impact of work/academic performance, impact of social activity level and anxiety level in women with primary dysmenorrhea (PD) complaints.
Read the detailed description
PD is the cramping pain that comes before or during a menstrual period. Relaxation training contributes to the reduction of stress and pain. Thus, there is a need to investigate the effects of relaxation training in dysmenorrhea.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Relaxation training, No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation trainingOther
Relaxation training will be performed under the supervision of a physiotherapist. The training is carried out from the estimated day of ovulation (cycle length in days minus 14) until the next menstrual period begins
No interventionOther
No intervention will be applied. The natural process will be followed from the estimated day of ovulation (cycle length in days minus 14) until the next menstrual period begins
| Study group | Role | What they receive |
|---|---|---|
| Relaxation group | Experimental | Jacobson progressive relaxation training will be applied Receives: Other: Relaxation training |
| Control group | Other | No intervention will be applied Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menstrual pain intensity
Menstrual pain intensity will be evaluated with Visual Analogue Scale. This scale consists of a 10 cm horizontal line. The starting point "0" = "no pain", while "10" = "unbearable pain". Individuals will be asked to mark on a 10 cm straight line according to the level of pain they feel. Pain intensity will be recorded by measuring the distance between the beginning of the line and the marked place.
Measured: change from baseline at an average of 2 weeks
Secondary outcomes (5)
Menstrual symptoms
Menstrual symptoms will be measured with the menstrual symptom questionnaire. Menstrual Symptom Questionnaire is a 24-item self-report scale and each item is scored between 1 (never) and 5 (always). An increase in the mean score indicates an increase in the severity of menstrual symptoms. The total score is 120 points.
Measured: change from baseline at an average of 2 weeks
Impacts of academic/work performance
Impacts of academic/work performance will be evaluated with Visual Analogue Scale. This scale consists of a 10 cm horizontal line. The starting point "0"= means "my work/school performance is not affected in any way", while "10"= means "my work/school performance is greatly affected"
Measured: change from baseline at an average of 2 weeks
Impacts of life quality
Impacts of life quality will be evaluated with Visual Analogue Scale. This scale consists of a 10 cm horizontal line. The starting point "0" = "my quality of life is not affected in any way", while "10" = "my quality of life is greatly affected". Individuals will be asked to mark on a 10 cm straight line according to the quality of life they think.
Measured: change from baseline at an average of 2 weeks
Impacts of social activity
Impacts of social activity will be evaluated with Visual Analogue Scale. This scale consists of a 10 cm horizontal line. The starting point "0" = "my social activity is not affected in any way", while "10" = "my social activity is greatly affected". Individuals will be asked to mark on a 10 cm straight line according to the social activity they think.
Measured: change from baseline at an average of 2 weeks
Anxiety level
Anxiety level will be assessed with the Spielberger State Trait Anxiety Inventory. This inventory is a 40-item self-report inventory designed to measure both state anxiety section (current feelings of apprehension, worry, etc.) and trait anxiety section (continuous feelings of apprehension, worry, etc.). Each section is scored on four levels of anxiety intensity from 1="not at all" to 4="very much" and with a sum score between 20 and 80. A higher total score indicates more severe anxiety level.
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 posted14 Apr 2022
- Study start15 May 2022 (estimated)
- Primary completion15 Oct 2022 (estimated)
- Study completion15 Dec 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.
- More trials run by Ankara Yildirim Beyazıt 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seyda toprak celenay, Ankara Yildirim Beyazıt University
- Investigators
- Seyda Toprak Celenay, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328869
- Sponsor's protocol ID
- 2022/04/07
- Status last verified
- Apr 2022
- First submitted
- 7 Apr 2022
- Last updated
- 14 Apr 2022
- 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 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Of Relaxation Training In Women With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT05328869
- Acronym / sponsor ID
- 2022/04/07
- Conditions
- Primary Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 15 May 2022 (estimated)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 14 Apr 2022 (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 investigate the effects of relaxation training on menstrual pain severity, menstrual symptoms, impact of quality of life, impact of work/academic performance, impact of social activity level and anxiety level in women with primary dysmenorrhea (PD) complaints.
Detailed description
PD is the cramping pain that comes before or during a menstrual period. Relaxation training contributes to the reduction of stress and pain. Thus, there is a need to investigate the effects of relaxation training in dysmenorrhea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relaxation group | Experimental | Other: Relaxation trainingJacobson progressive relaxation training will be applied |
| Control group | Other | Other: No interventionNo intervention will be applied |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women with primary dysmenorrhea complaint according to the Primary Dysmenorrhea Consensus Guide,
- Over 18 years of age,
- Having a mean pain intensity of moderate and higher according to the Visual Analogue Scale in the last 6 months,
- Having a regular menstrual cycle (28±7 days),
- Volunteered to participate in the study.
Key exclusion criteria (10 listed)
- Having a pathological history and radiological findings pointing to secondary dysmenorrhea,
- Using oral contraceptives/antidepressants at least 6 months,
- Receiving hormone therapy,
- Undergoing pelvic surgery,
- Pregnant,
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 |
|---|---|---|
| Relaxation trainingRelaxation training will be performed under the supervision of a physiotherapist. The training is carried out from the estimated day of ovulation (cycle length in days minus 14) until the next menstrual period begins | Other | Relaxation group |
| No interventionNo intervention will be applied. The natural process will be followed from the estimated day of ovulation (cycle length in days minus 14) until the next menstrual period begins | Other | Control group |
Primary outcome
Menstrual pain intensity
Time frame: change from baseline at an average of 2 weeks
Menstrual pain intensity will be evaluated with Visual Analogue Scale. This scale consists of a 10 cm horizontal line. The starting point "0" = "no pain", while "10" = "unbearable pain". Individuals will be asked to mark on a 10 cm straight line according to the level of pain they feel. Pain intensity will be recorded by measuring the distance between the beginning of the line and the marked place.
5 secondary outcomes
Menstrual symptoms
Time frame: change from baseline at an average of 2 weeks
Impacts of academic/work performance
Time frame: change from baseline at an average of 2 weeks
Impacts of life quality
Time frame: change from baseline at an average of 2 weeks
Impacts of social activity
Time frame: change from baseline at an average of 2 weeks
Anxiety level
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 14 Apr 2022.
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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 Relaxation training in people with Primary Dysmenorrhea, run by Ankara Yildirim Beyazıt University.
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 5 inclusion and 10 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 14 Apr 2022. 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?
Menstrual 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 14 Apr 2022.