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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
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.

dilek bingöl, MSc contact

+90 5539720286

bngldilek.05@gmail.com

melike dişsiz, PhD contact

+90 5437995143

melike.dissiz@sbu.edu.tr

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 groups in NCT06961552
Study groupRoleWhat they receive
reflexology massage groupExperimentalNot described
Receives: Other: reflexology masaj group
control groupNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Premenstrual Syndrome Symptoms

    Evaluation with Premenstrual Syndrome Scale

    Measured: 7 months

Secondary outcomes (1)
  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.

  1. First posted8 May 2025
  2. Study start1 Jul 2025 (estimated)
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

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)
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

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.

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