Premenstrual SyndromeNCT03899207
Acupressure and Training for Coping With PMS
A study testing training +acupressure and training in people with Premenstrual Syndrome and Acupressure, run by Adiyaman University Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
The study was conducted to determine the effect of acupressure and training, given to women under the guidance of health belief model for coping with premenstrual syndrome, on the premenstrual symptoms and quality of life. This study was conducted to as a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Premenstrual Syndrome, Acupressure
- What is being tested?
- training +acupressure and training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 30 Jun 2017to 20 Apr 2018
- 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
- Having regular menstruation (between 21-35 days),
- not having any psychiatric diagnosis or any gynecological diseases
- not using contraceptives,
- not having tissue deformity in the extremities.
Who cannot join
- having any psychiatric diagnosis having any gynecological diseases
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
DİDEM
Adıyaman, 02100
ınönü Universty
Malatya, 02100
About this study
Official title: Adiyaman University School of Health
The study was conducted to determine the effect of acupressure and training, given to women under the guidance of health belief model for coping with premenstrual syndrome, on the premenstrual symptoms and quality of life.
This study was conducted to as a randomized controlled trial. The population of the study was composed of all women with PMS registered in FHCs no. 4 and 14 located in the city center. The sample of the study consisted of women including 51 women in training +acupressure group, 55 women in training group and 57 women in control group. The data were collected with Participant Information Form, PMSS and WHOQOL-BREF in the study. Training and acupressure were administered to the acupressure + training group. Only the training for coping with premenstrual syndrome was given to the training group. The data collection forms were reapplied to all groups 12 weeks after the pretest.
Read the detailed description
Premenstrual Syndrome is an important collection of symptoms affecting approximately one-fifth of women in reproductive age.
Acupressure is an intervention found in the nursing intervention system and defined as applying constant and powerful pressure on certain/specific points of the body in order to reduce pain, provide relaxation and relief, and to prevent or reduce nausea. Many studies conducted in gynecology have shown that acupressure decreased menstrual distress, premenstrual symptoms, back pain in women experiencing dysmenorrhea, labor pain and nausea and vomiting during pregnancy. In addition, it was shown in the studies that training given for PMS decreased the premenstrual symptoms
- Conditions
- Premenstrual Syndrome, Acupressure
- Being tested
- training +acupressure, training
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
training +acupressureOther
.Training+acupressure group; received training for coping with PMS prepared under the guidance of HBM and "The Booklet of Training for Coping with Premenstrual Symptoms" including information about the training given. In addition to the training, acupressure was applied by the researcher twice a week and 24 times in total. Acupressure application was continued with the same frequency until the end of the study (24 times in total for 3 months). One month after the first home visit, reminder training for coping with premenstrual symptoms was given to the women
trainingOther
Training Group; received the training for coping with PMS prepared under the guidance of HBM and "The Booklet of Training for Coping with Premenstrual Symptoms" including information about the training given. One month after the first home visit, reminder training was given to the women.
| Study group | Role | What they receive |
|---|---|---|
| training +acupressure | Experimental | In the training+acupressure group, 10 women were excluded from the study since they could not participate in acupressure application at different times, 2 women were excluded since they had menstrual irregularities and 4 women were excluded since they could not be contacted. Receives: Other: training |
| training | Experimental | In the training group, 4 women were excluded since they did not participate in the reminder training, 1 woman was excluded since she had menstrual irregularities, 3 women were excluded since they wanted to withdraw from the study and 3 women were excluded from the study since they could not be contacted. Receives: Other: training +acupressure |
| control | No intervention | In the control group, 4 women were excluded from the study since they could not be reached and 5 women were excluded since they did not agree to participate in the posttest. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effects of Health Belief Model-Based Training for Coping with Premenstrual Syndrome and Acupressure on Premenstrual Symptoms and Quality of Life
The premenstrual syndrome scale,The lowest score to be taken from the scale is 44 and the highest score is 220. High score shows an increase in the intensity of the symptoms of premenstrual syndrome. If the total scale score is higher than 50% (110) of the highest score (220) in PMS scale, PMS is considered as "present".In the calculation of WHOQOL-BREF scoring, 1st and 2nd items are evaluated independently while the answers obtained from the 3rd, 4th, 26th and 27th questions are reversely scored since they indicate negative statements. The scale does not have a total score. Higher scores obtained from the subscales of the scale indicate that the quality of life level is high.
Measured: 10 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start30 Jun 2017
- Primary completion20 Nov 2017
- Study completion20 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomize control trail
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Didem Kucukkelepce, Adiyaman University Research Hospital
- Investigators
- Didem Simsek Kucukkelepce, phd, Principal investigator, World Health Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899207
- Sponsor's protocol ID
- Adiyaman Universty
- Status last verified
- Aug 2019
- First submitted
- 20 Mar 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adiyaman University School of Health
- ClinicalTrials.gov ID
- NCT03899207
- Acronym / sponsor ID
- Adiyaman Universty
- Conditions
- Premenstrual Syndrome, Acupressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 20 Apr 2018 (actual)
- First posted
- 2 Apr 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 was conducted to determine the effect of acupressure and training, given to women under the guidance of health belief model for coping with premenstrual syndrome, on the premenstrual symptoms and quality of life.
This study was conducted to as a randomized controlled trial. The population of the study was composed of all women with PMS registered in FHCs no. 4 and 14 located in the city center. The sample of the study consisted of women including 51 women in training +acupressure group, 55 women in training group and 57 women in control group. The data were collected with Participant Information Form, PMSS and WHOQOL-BREF in the study. Training and acupressure were administered to the acupressure + training group. Only the training for coping with premenstrual syndrome was given to the training group. The data collection forms were reapplied to all groups 12 weeks after the pretest.
Detailed description
Premenstrual Syndrome is an important collection of symptoms affecting approximately one-fifth of women in reproductive age.
Acupressure is an intervention found in the nursing intervention system and defined as applying constant and powerful pressure on certain/specific points of the body in order to reduce pain, provide relaxation and relief, and to prevent or reduce nausea. Many studies conducted in gynecology have shown that acupressure decreased menstrual distress, premenstrual symptoms, back pain in women experiencing dysmenorrhea, labor pain and nausea and vomiting during pregnancy. In addition, it was shown in the studies that training given for PMS decreased the premenstrual symptoms
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- randomize control trail
| Arm | Type | Receives |
|---|---|---|
| training +acupressure | Experimental | Other: trainingIn the training+acupressure group, 10 women were excluded from the study since they could not participate in acupressure application at different times, 2 women were excluded since they had menstrual irregularities and 4 women were excluded since they could not be contacted. |
| training | Experimental | Other: training +acupressureIn the training group, 4 women were excluded since they did not participate in the reminder training, 1 woman was excluded since she had menstrual irregularities, 3 women were excluded since they wanted to withdraw from the study and 3 women were excluded from the study since they could not be contacted. |
| control | No intervention | –In the control group, 4 women were excluded from the study since they could not be reached and 5 women were excluded since they did not agree to participate in the posttest. |
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)
- Having regular menstruation (between 21-35 days),
- not having any psychiatric diagnosis or any gynecological diseases
- not using contraceptives,
- not having tissue deformity in the extremities.
Key exclusion criteria (1 listed)
- having any psychiatric diagnosis having any gynecological diseases
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 |
|---|---|---|
| training +acupressure.Training+acupressure group; received training for coping with PMS prepared under the guidance of HBM and "The Booklet of Training for Coping with Premenstrual Symptoms" including information about the training given. In addition to the training, acupressure was applied by the researcher twice a week and 24 times in total. Acupressure application was continued with the same frequency until the end of the study (24 times in total for 3 months). One month after the first home visit, reminder training for coping with premenstrual symptoms was given to the women | Other | training |
| trainingTraining Group; received the training for coping with PMS prepared under the guidance of HBM and "The Booklet of Training for Coping with Premenstrual Symptoms" including information about the training given. One month after the first home visit, reminder training was given to the women. | Other | training +acupressure |
Primary outcome
The Effects of Health Belief Model-Based Training for Coping with Premenstrual Syndrome and Acupressure on Premenstrual Symptoms and Quality of Life
Time frame: 10 month
The premenstrual syndrome scale,The lowest score to be taken from the scale is 44 and the highest score is 220. High score shows an increase in the intensity of the symptoms of premenstrual syndrome. If the total scale score is higher than 50% (110) of the highest score (220) in PMS scale, PMS is considered as "present".In the calculation of WHOQOL-BREF scoring, 1st and 2nd items are evaluated independently while the answers obtained from the 3rd, 4th, 26th and 27th questions are reversely scored since they indicate negative statements. The scale does not have a total score. Higher scores obtained from the subscales of the scale indicate that the quality of life level is high.
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 28 Aug 2019.
- Individual participant dataSharing planned: No
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A Clinical Trial to Evaluate the Effects of the Kaia Relief - Cycle System on Premenstrual Symptom Severity, Menstrual Discomfort, and Overall Well-Being in Premenopausal Women.
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Occupational Physicians Facing Premenstrual Dysphoric Disorder: Knowledge, Perceptions and Practices in Occupational Health
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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.
Didem Simsek Kucukkelepce, phd principal investigator
World Health Organization
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing training +acupressure and training in people with Premenstrual Syndrome and Acupressure, run by Adiyaman University Research Hospital at 2 sites 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 4 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 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 Effects of Health Belief Model-Based Training for Coping with Premenstrual Syndrome and Acupressure on Premenstrual Symptoms and Quality of Life (time frame: 10 month). 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 28 Aug 2019.