Reflexology Versus Acupressure on Sleep Disturbance and Hot Flashes

NCT ID: NCT06499311

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2024-08-20

Brief Summary

World health Organization (WHO) estimates that by 2030, 1.2 billion women will be over 50 years old. With a prevalence of 70%, a hot flash is the most distressing symptoms associated with menopause. Postmenopausal associated sleep disturbances could affect those women social activities and one's daily positive functioning. Therefore, some patients and their providers seek alternative treatments such as relaxation techniques, acupressure, yoga, reflexology, regular exercise, balanced nutrition, herbal supplements, appropriate clothing, and frequent showers, have been shown to be effective in reducing symptoms associated with depression. So, this study will be the first one in this issue. Therefore, it will have valuable benefits in physical therapy field and scientific research.

Detailed Description

Fifty-four postmenopausal women suffering from moderate to severe hot flashes diagnosed with hot flashes questionnaire, and sleep disturbances diagnosed with Pittsburgh quality sleep index >5. Their age ranged from 45-55 years old with their body mass index ranged from 25 to 30 kilogram per meter square. Outcome measures were Pittsburgh sleep quality index and Hot flashes questionnaire, both were conducted at baseline and after the end of the study program. after recruiting study population, they will be divided into two equal groups randomly. Group A; will received foot reflexology (medical border just above the heel, reflex points associated with adrenal, hypothalamus, pituitary glands, heart and lung via manual pressure at reflexology zone), for 15 minutes, 3 sessions per week for 6 weeks. Group B; will received acupressure ((Shenmen point, Sanyinjiao point, Fengchi point; Yintang point), for 21 minutes, 3 sessions per week for 6 weeks.

Conditions

Postmenopausal Flushing; Hot Flashes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group A; Foot Reflexology

Foot reflexology for 15 minutes, 3 sessions per week for 6 weeks will applied at the medical border just above the heel, also at associated reflex points associated with the adrenal, hypothalamus, pituitary glands, heart and lung via manual pressure at reflexology zone.

Group Type: EXPERIMENTAL

Foot Reflexology

Intervention Type: OTHER

Foot Reflexology is an alternative medical practice involving the application of pressure to specific points on the feet. It has been reported as a non-invasive complementary therapy that was addressed as an effective technique that is reported to reduce premenstrual symptoms.

Group B; Acupressure

Acupressure for 21 minutes, 3 sessions per week for 6 weeks will applied at four acupoints points (Shenmen point at wrist crease, Sanyinjiao point; at both feet, and Fengchi point; at hairline within occipital region on dorsal neck surface), bilaterally in addition to one in midline at the top of nose on centerline between eyebrows ends (Yintang point).

Group Type: EXPERIMENTAL

Acupressure

Intervention Type: OTHER

Acupressure is a sort of massage therapy, was addressed as an effective technique that is reported to reduce premenstrual symptoms. Acupressure is a well-known form of Traditional Chinese Medicine that is a component of alternative treatments.

Interventions

Foot Reflexology

Foot Reflexology is an alternative medical practice involving the application of pressure to specific points on the feet. It has been reported as a non-invasive complementary therapy that was addressed as an effective technique that is reported to reduce premenstrual symptoms.

Intervention Type: OTHER

Acupressure

Acupressure is a sort of massage therapy, was addressed as an effective technique that is reported to reduce premenstrual symptoms. Acupressure is a well-known form of Traditional Chinese Medicine that is a component of alternative treatments.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ranged from 45 to 55 years old.
• Their body mass index ranged from 25 to 3 kilograms per meter square.
• Postmenopausal women suffering from moderate to sever hot flashes assessed by Hot Flashes Questionnaire.
• Postmenopausal women suffering from sleep disturbances more than five assessed by Pittsburgh sleep quality index.

Exclusion Criteria

• Any emotional stress during at least 6 months.
• Any pharmacological medicines lead to sleep disturbances.
• Any mental disorders affect their sleep cycle.
• Taking hormone replacement therapy for the past six months.
• Using herbal medicine to improve menopausal symptoms severity.
• Circular job in particular night shifts.
• Sensorineural problems in their feet.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Yasmeen Samir Abdelazeem Ali

Physical Therapist Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Walid M Zidan, PHD

Role: STUDY_CHAIR

Head and Professor of Obstetrics and Gynecology Department

Locations

Faculty of Physical Therapy

Giza, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Dr Mohamed A Awad, PHD

Role: CONTACT

awad18111972@yahoo.com

00201224955140

Elham S Hassan, PHD

Role: CONTACT

elhamramadan70@cu.edu.eg

00201206146539

Facility Contacts

Elham S Hassan, PHD.

Role: primary

elhamramadan70@cu.edu.eg

00201206146539

Mohamed A Awad, PHD

Role: backup

awad18111972@yahoo.com

00201224955140

Other Identifiers

REC/012/005081

Identifier Type: -

Identifier Source: org_study_id