ReflexologyNCT04348201
Foot Reflexology on Premenstrual Syndrome
A study testing foot reflexology and dietary modification in people with Reflexology and Dietary Modification, run by Cairo University.
Trial summary
: Premenstrual Syndrome (PMS) is a set of physical, emotional and behavioral symptom that start during the week preceding menstruation and are alleviated when the menstrual flow begins. Reflexology is one of the most popular complementary therapies Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Reflexology, Dietary Modification
- What is being tested?
- foot reflexology and dietary modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 24 Jun 2010to 30 Jan 2020
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- their age ranged from 18 to 25 years old
- their body mass index (BMI) did not exceed 30kg/m2
Who cannot join
- Rheumatoid arthritis
- Bronchial asthma
- depression
- anxiety
About this study
Official title: Foot Reflexology Combined With Dietary Modification on Premenstrual Syndrome
: Premenstrual Syndrome (PMS) is a set of physical, emotional and behavioral symptom that start during the week preceding menstruation and are alleviated when the menstrual flow begins. Reflexology is one of the most popular complementary therapies
Read the detailed description
This study was aimed to determine the effect of foot reflexology in the treatment of premenstrual syndrome. Subjects and methods: Fifty volunteer, single females with premenstrual syndrome (PMS) were selected randomly from outpatient clinic of obstetrics and gynecology at Kasr El Ainy University Hospital, Faculty of Medicine, Cairo University to share in this study, their age ranged from 18 to 25 years old and their body mass index (BMI) did not exceed 30kg/m2, the participants were assigned into two groups of equal numbers. The group (A) received therapeutic foot reflexology with dietary modification 3 times/week for8 weeks, while the group (B) received dietary modifications only for 8 weeks. All subjects in both groups were assessed through the visual analogue scale (VAS) for pain and Premenstrual Daily Symptoms Questionnaire for (PMS) related symptoms. Results: The results of the present study revealed that there was statistically significant improvement in both pain and premenstrual related symptoms in group (A) than in group (B).
- Conditions
- Reflexology, Dietary Modification
- Being tested
- foot reflexology, dietary modification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
foot reflexologyOther
foot reflexology session which takes about 20 minutes. The position of the patient during reflexology session was a relaxed comfortable supine lying position. The therapist was sitting position at the level of the feet. The Session of reflexology was done on three points at both feet.
dietary modificationDietary supplement
diet must be rich in vitamins as fish and beans, calcium as milk and chess, low fat food through decrease oil in meals, high fiber food through all types of vegetables and fruits and restrict caffeine
| Study group | Role | What they receive |
|---|---|---|
| foot reflexology | Active comparator | foot reflexology session which takes about 20 minutes. Receives: Other: foot reflexology |
| dietary modification | Active comparator | diet must be rich in vitamins. Receives: Dietary Supplement: dietary modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
was used to measure the severity of pain for each female in both groups (A, B) before and after the treatment according to 5 cm calibrated line with 0 (zero) representing no pain and 5 representing worst pain, each female in both groups (A\&B) would be asked to mark on the line that represents her level of pain before and after treatment.
Measured: 8 weeks
Secondary outcomes (1)
Premenstrual daily symptoms questionnaire
were taken for all participants in both groups (A\&B) through asked all patients all questions in the questionnaire by: were you have symptoms such as: tension, anger, anxiety, depression and crying
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start24 Jun 2010
- Primary completion30 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ReflexologyStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- Fifty volunteer, single females with premenstrual syndrome (PMS) were selected randomly from outpatient clinic of obstetrics and gynecology at Kasr El Ainy University Hospital, Faculty of Medicine, Cairo University to share in this study, their age ranged from 18 to 25 years old and their body mass index (BMI) did not exceed 30kg/m2, the participants were assigned into two groups of equal numbers. The group (A) received therapeutic foot reflexology with dietary modification 3 times/week for8 weeks, while the group (B) received dietary modifications only for 8 weeks
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Ebrahim El Refaye, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348201
- Sponsor's protocol ID
- Cairo Un 89
- Status last verified
- Apr 2020
- First submitted
- 10 Apr 2020
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foot Reflexology Combined With Dietary Modification on Premenstrual Syndrome
- ClinicalTrials.gov ID
- NCT04348201
- Acronym / sponsor ID
- Cairo Un 89
- Conditions
- Reflexology, Dietary Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 24 Jun 2010 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 16 Apr 2020 (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.
: Premenstrual Syndrome (PMS) is a set of physical, emotional and behavioral symptom that start during the week preceding menstruation and are alleviated when the menstrual flow begins. Reflexology is one of the most popular complementary therapies
Detailed description
This study was aimed to determine the effect of foot reflexology in the treatment of premenstrual syndrome. Subjects and methods: Fifty volunteer, single females with premenstrual syndrome (PMS) were selected randomly from outpatient clinic of obstetrics and gynecology at Kasr El Ainy University Hospital, Faculty of Medicine, Cairo University to share in this study, their age ranged from 18 to 25 years old and their body mass index (BMI) did not exceed 30kg/m2, the participants were assigned into two groups of equal numbers. The group (A) received therapeutic foot reflexology with dietary modification 3 times/week for8 weeks, while the group (B) received dietary modifications only for 8 weeks. All subjects in both groups were assessed through the visual analogue scale (VAS) for pain and Premenstrual Daily Symptoms Questionnaire for (PMS) related symptoms. Results: The results of the present study revealed that there was statistically significant improvement in both pain and premenstrual related symptoms in group (A) than in group (B).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Fifty volunteer, single females with premenstrual syndrome (PMS) were selected randomly from outpatient clinic of obstetrics and gynecology at Kasr El Ainy University Hospital, Faculty of Medicine, Cairo University to share in this study, their age ranged from 18 to 25 years old and their body mass index (BMI) did not exceed 30kg/m2, the participants were assigned into two groups of equal numbers. The group (A) received therapeutic foot reflexology with dietary modification 3 times/week for8 weeks, while the group (B) received dietary modifications only for 8 weeks
| Arm | Type | Receives |
|---|---|---|
| foot reflexology | Active comparator | Other: foot reflexologyfoot reflexology session which takes about 20 minutes. |
| dietary modification | Active comparator | Dietary Supplement: dietary modificationdiet must be rich in vitamins. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- their age ranged from 18 to 25 years old
- their body mass index (BMI) did not exceed 30kg/m2
Key exclusion criteria (4 listed)
- Rheumatoid arthritis
- Bronchial asthma
- depression
- anxiety
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 |
|---|---|---|
| foot reflexologyfoot reflexology session which takes about 20 minutes. The position of the patient during reflexology session was a relaxed comfortable supine lying position. The therapist was sitting position at the level of the feet. The Session of reflexology was done on three points at both feet. | Other | foot reflexology |
| dietary modificationdiet must be rich in vitamins as fish and beans, calcium as milk and chess, low fat food through decrease oil in meals, high fiber food through all types of vegetables and fruits and restrict caffeine | Dietary supplement | dietary modification |
Primary outcome
Visual analogue scale
Time frame: 8 weeks
was used to measure the severity of pain for each female in both groups (A, B) before and after the treatment according to 5 cm calibrated line with 0 (zero) representing no pain and 5 representing worst pain, each female in both groups (A\&B) would be asked to mark on the line that represents her level of pain before and after treatment.
1 secondary outcome
Premenstrual daily symptoms questionnaire
Time frame: 8 weeks
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 17 Apr 2020.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing foot reflexology and dietary modification in people with Reflexology and Dietary Modification, run by Cairo 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 2 inclusion and 4 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 17 Apr 2020. 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?
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?
Visual analogue scale (time frame: 8 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 17 Apr 2020.