Clinical trial NCT06499311: Reflexology Versus Acupressure on Sleep Disturbance and Hot Flashes
Official title: Effect of Foot Reflexology Versus Acupressure on Sleep Disturbance and Hot Flashes in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postmenopausal Flushing
Hot Flashes
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 54
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, randomized, controlled trial.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: Pretreatment and immediately Posttreatment.
Secondary outcomes:
measure: Hot Flashes Questionnaire
timeFrame: Pretreatment and immediately Posttreatment.
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
affiliation: Head and Professor of Obstetrics and Gynecology Department
name: Walid M Zidan, PHD
role: STUDY_CHAIR
References: