Effect of Reflexology on Premenstrual Syndrome SymptomsNCT06961552
The Effect of Reflexology on Premenstrual Syndrome Symptoms, Pain and Quality of Life
A study testing reflexology masaj group in people with Effect of Reflexology on Premenstrual Syndrome Symptoms, run by Saglik Bilimleri Universitesi.
Trial summary
This study was planned as a randomized controlled experimental study to examine the effect of reflexology on premenstrual syndrome symptoms, pain and quality of life in women with premenstrual syndrome between January 2025 and December 2025. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Effect of Reflexology on Premenstrual Syndrome Symptoms
- What is being tested?
- reflexology masaj group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Inclusion Criteria Women who are 18 years of age or older, No communication problems, Scoring 111 and above on the Premenstrual Syndrome Scale, Having regular menstruation for the last six months, Having a menstrual cycle of 22-35 days, Having a menstrual period of no longer than 7 days, Not receiving medical or surgical treatment for PMS, Having no other gynecological problems, Having no psychiatric problems, Women who have no chronic illness in the last three months and have not undergone any gynecological surgery
Exclusion Criteria Women who score 110 or less on the Premenstrual Syndrome Scale, Women who are pregnant, Women who use hormonal contraception (such as oral contraceptives and injections), Women who have another gynecological problem, Women who have psychiatric problems, Women who have ulcers, varicose veins, thrombus, phlebitis, ecchymosis, hematoma, infection on both feet, women with impaired skin integrity, and women who have a history of foot surgery will not be included in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study was planned as a randomized controlled experimental study to examine the effect of reflexology on premenstrual syndrome symptoms, pain and quality of life in women with premenstrual syndrome between January 2025 and December 2025.
A total of 70 women, 35 in the experimental group and 35 in the control group, who applied to the gynecology outpatient clinic with premenstrual syndrome symptoms, met the inclusion criteria and agreed to participate in the study voluntarily will constitute the sample.
The women in the reflexology group will receive a reflexology massage for two cycles by the researcher, starting at the end of menstruation (on the 5th-7th days of the cycle), for a total of 30 minutes, with proven applications specific to the region, pressure sliding and circular pressure applied to the reflexology distribution points on the foot bones three times, with baby oil. A total of 8 reflexology massage sessions will be performed, one day a week (Monday) for 8 weeks, one session. No intervention will be made to the control group.
Read the detailed description
The menstrual cycle is defined as a periodic preparation period for fertilization and pregnancy that begins after puberty and continues until menopause. Women may experience some symptoms commonly in the premenstrual and menstrual periods during the menstrual cycle, which is a physiological process.
Premenstrual syndrome is a condition that is seen in the late luteal phase of the menstrual cycle, recurs in most cycles, rapidly improves with menstruation, and is not seen for at least one week in the follicular phase, and in which cognitive, physical, somatic and emotional behavioral changes are observed. PMS symptoms typically begin after the 13th day of the menstrual cycle. It is suggested that it is difficult to determine the true prevalence due to the variety of PMS symptoms. International studies report that the prevalence of PMS varies between 7.1% and 99.5%. Similarly, studies conducted in Turkey report that the prevalence of PMS is between 33-92.3%.
The severity and occurrence of PMS symptoms vary from woman to woman. Physical symptoms seen in PMS are appetite changes, weight gain, nausea, abdominal distension, diarrhea, constipation, breast tenderness, fullness, hot flushes, acne, muscle and joint pain, and headache. Behavioral symptoms are changes in sexual desire, changes in work habits, social withdrawal, avoidance of human relations, crying spells, tendency to fight, apathy, difficulty concentrating, and sleep disorders. Psychological symptoms are forgetfulness, decreased self-esteem, feelings of inadequacy, guilt, paranoia, irritability, anxiety, restlessness, hypersensitivity to sound and light, loneliness, suicidal thoughts, psychosis, confusion, variable and depressive mood, decreased concentration, and a feeling of losing control. PMS also has a very negative effect on women's quality of life. Premenstrual symptoms can lead to increased accident potential and economic losses. It can also negatively affect young girls' emotional well-being, self-confidence, academic success, attendance at classes, work quality, daily activities, social activities, social relations, family relations and quality of life.
Reflexology is a holistic and complementary treatment method. Unlike regular massage, a special pressure technique is used to apply rubbing, patting and squeezing movements to reflex points. The thumb and index finger are mostly used to apply pressure. The International Reflexology Institute defines reflexology as "a technique that is applied manually to reflex points on the hands, feet and ears, which are associated with all glands, organs and body parts, and helps normalize body functions." Reflexology has been used since ancient times to balance the energy in the body, provide healing and increase relaxation.
In recent years, it has been reported that reflexology reduces fatigue, insomnia, stress, anxiety, depression, dyspnea, migraine pain, rheumatic muscle pain and spasm, supports general rehabilitation practices in neurological diseases such as multiple sclerosis, reduces nausea, vomiting and constipation, alleviates some urinary system problems, cancer pain and side effects of chemotherapy, facilitates birth, reduces pain during birth, after birth and after surgery, premenstural syndrome (PMS) and dysmenorrhea complaints, vasomotor problems in menopause, infantile colic and pain in babies, regulates the sedation level and vital signs of patients. The top five issues are pain (28.1%), fatigue (21.9%), anxiety (18.8%), quality of life (15.6%) and sleep quality (12.5%).
Nurses are health professionals who support women with PMS from the first stage of symptom management. Health education is very important in coping with PMS. Education should raise awareness that menstruation is a normal process, PMS is a problem, and that a specialist should be consulted when necessary. In addition, women should be supported and educated about healthy living and the necessary interventions to alleviate premenstrual symptoms before using analgesics, which is the first method used to cope with premenstrual symptoms. Nurses can also benefit from non-pharmacological methods to reduce the effects of premenstrual symptoms, support women in continuing their daily activities, increase their quality of life, and also provide pain and stress management. They can recommend non-pharmacological methods such as reflexology, meditation, yoga, distraction, imagination, massage, showering, hot and cold application, and relaxation techniques such as adequate sleep and rest.
- Being tested
- reflexology masaj group
- Keywords
- reflexology, Premenstrual Syndrome-PMS, Pain, Quality of Life
- Medical subject headings
- Premenstrual Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reflexology masaj groupOther
The women in the reflexology group will receive a reflexology massage with proven regional applications, pressure sliding and circular pressure three times with baby oil for two cycles by the researcher, starting at the end of menstruation (5-7th days of the cycle), for a total of 30 minutes in a single session for each foot, starting at 15 minutes per foot. A total of 8 reflexology massage sessions will be performed, one session per week (Monday) for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| reflexology massage group | Experimental | Not described Receives: Other: reflexology masaj group |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premenstrual Syndrome Symptoms
Evaluation with Premenstrual Syndrome Scale
Measured: 7 months
Secondary outcomes (1)
Pain situation
Evaluation with Visual Comparison Scale
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start1 Jul 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Reflexology on Premenstrual Syndrome SymptomsStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Bingöl, Saglik Bilimleri Universitesi
- Investigators
- melike dişsiz, PhD, Study director, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961552
- Sponsor's protocol ID
- SBU-DB
- Status last verified
- May 2025
- First submitted
- 21 Apr 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reflexology on Premenstrual Syndrome Symptoms, Pain and Quality of Life
- ClinicalTrials.gov ID
- NCT06961552
- Acronym / sponsor ID
- SBU-DB
- Keywords
- reflexology, Premenstrual Syndrome-PMS, Pain, Quality of Life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 8 May 2025 (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.
This study was planned as a randomized controlled experimental study to examine the effect of reflexology on premenstrual syndrome symptoms, pain and quality of life in women with premenstrual syndrome between January 2025 and December 2025.
A total of 70 women, 35 in the experimental group and 35 in the control group, who applied to the gynecology outpatient clinic with premenstrual syndrome symptoms, met the inclusion criteria and agreed to participate in the study voluntarily will constitute the sample.
The women in the reflexology group will receive a reflexology massage for two cycles by the researcher, starting at the end of menstruation (on the 5th-7th days of the cycle), for a total of 30 minutes, with proven applications specific to the region, pressure sliding and circular pressure applied to the reflexology distribution points on the foot bones three times, with baby oil. A total of 8 reflexology massage sessions will be performed, one day a week (Monday) for 8 weeks, one session. No intervention will be made to the control group.
Detailed description
The menstrual cycle is defined as a periodic preparation period for fertilization and pregnancy that begins after puberty and continues until menopause. Women may experience some symptoms commonly in the premenstrual and menstrual periods during the menstrual cycle, which is a physiological process.
Premenstrual syndrome is a condition that is seen in the late luteal phase of the menstrual cycle, recurs in most cycles, rapidly improves with menstruation, and is not seen for at least one week in the follicular phase, and in which cognitive, physical, somatic and emotional behavioral changes are observed. PMS symptoms typically begin after the 13th day of the menstrual cycle. It is suggested that it is difficult to determine the true prevalence due to the variety of PMS symptoms. International studies report that the prevalence of PMS varies between 7.1% and 99.5%. Similarly, studies conducted in Turkey report that the prevalence of PMS is between 33-92.3%.
The severity and occurrence of PMS symptoms vary from woman to woman. Physical symptoms seen in PMS are appetite changes, weight gain, nausea, abdominal distension, diarrhea, constipation, breast tenderness, fullness, hot flushes, acne, muscle and joint pain, and headache. Behavioral symptoms are changes in sexual desire, changes in work habits, social withdrawal, avoidance of human relations, crying spells, tendency to fight, apathy, difficulty concentrating, and sleep disorders. Psychological symptoms are forgetfulness, decreased self-esteem, feelings of inadequacy, guilt, paranoia, irritability, anxiety, restlessness, hypersensitivity to sound and light, loneliness, suicidal thoughts, psychosis, confusion, variable and depressive mood, decreased concentration, and a feeling of losing control. PMS also has a very negative effect on women's quality of life. Premenstrual symptoms can lead to increased accident potential and economic losses. It can also negatively affect young girls' emotional well-being, self-confidence, academic success, attendance at classes, work quality, daily activities, social activities, social relations, family relations and quality of life.
Reflexology is a holistic and complementary treatment method. Unlike regular massage, a special pressure technique is used to apply rubbing, patting and squeezing movements to reflex points. The thumb and index finger are mostly used to apply pressure. The International Reflexology Institute defines reflexology as "a technique that is applied manually to reflex points on the hands, feet and ears, which are associated with all glands, organs and body parts, and helps normalize body functions." Reflexology has been used since ancient times to balance the energy in the body, provide healing and increase relaxation.
In recent years, it has been reported that reflexology reduces fatigue, insomnia, stress, anxiety, depression, dyspnea, migraine pain, rheumatic muscle pain and spasm, supports general rehabilitation practices in neurological diseases such as multiple sclerosis, reduces nausea, vomiting and constipation, alleviates some urinary system problems, cancer pain and side effects of chemotherapy, facilitates birth, reduces pain during birth, after birth and after surgery, premenstural syndrome (PMS) and dysmenorrhea complaints, vasomotor problems in menopause, infantile colic and pain in babies, regulates the sedation level and vital signs of patients. The top five issues are pain (28.1%), fatigue (21.9%), anxiety (18.8%), quality of life (15.6%) and sleep quality (12.5%).
Nurses are health professionals who support women with PMS from the first stage of symptom management. Health education is very important in coping with PMS. Education should raise awareness that menstruation is a normal process, PMS is a problem, and that a specialist should be consulted when necessary. In addition, women should be supported and educated about healthy living and the necessary interventions to alleviate premenstrual symptoms before using analgesics, which is the first method used to cope with premenstrual symptoms. Nurses can also benefit from non-pharmacological methods to reduce the effects of premenstrual symptoms, support women in continuing their daily activities, increase their quality of life, and also provide pain and stress management. They can recommend non-pharmacological methods such as reflexology, meditation, yoga, distraction, imagination, massage, showering, hot and cold application, and relaxation techniques such as adequate sleep and rest.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| reflexology massage group | Experimental | Other: reflexology masaj group |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| reflexology masaj groupThe women in the reflexology group will receive a reflexology massage with proven regional applications, pressure sliding and circular pressure three times with baby oil for two cycles by the researcher, starting at the end of menstruation (5-7th days of the cycle), for a total of 30 minutes in a single session for each foot, starting at 15 minutes per foot. A total of 8 reflexology massage sessions will be performed, one session per week (Monday) for 8 weeks. | Other | reflexology massage group |
Primary outcome
Premenstrual Syndrome Symptoms
Time frame: 7 months
Evaluation with Premenstrual Syndrome Scale
1 secondary outcome
Pain situation
Time frame: 7 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
Related trials for Effect of Reflexology on Premenstrual Syndrome Symptoms
Not yet recruiting
THE EFFECT OF A REFLEXOLOGY PROGRAM ON PREMENSTRUAL SYNDROME SYMPTOMS, QUALİTY OF LİFE AND GENERAL COMFORT
Premenstrual Syndrome-PMS
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.
melike dişsiz, PhD study director
Saglik Bilimleri Universitesi
Questions about this trial
What is this clinical trial studying?
A study testing reflexology masaj group in people with Effect of Reflexology on Premenstrual Syndrome Symptoms, run by Saglik Bilimleri Universitesi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 28 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact dilek bingöl, MSc (+90 5539720286, bngldilek.05@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Premenstrual Syndrome Symptoms (time frame: 7 months). 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 May 2025.