Reflexology Versus Acupressure on Sleep Disturbance and Hot Flashes

Effect of Foot Reflexology Versus Acupressure on Sleep Disturbance and Hot Flashes in Postmenopausal Women

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.

Study Overview

• Status: Recruiting
• Conditions: Hot Flashes; Postmenopausal Flushing
• Intervention / Treatment: Other: Foot Reflexology; Other: Acupressure

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.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Mohamed A Awad, PHD; Phone Number: 00201224955140; Email: awad18111972@yahoo.com
• Study Contact Backup: Name: Elham S Hassan, PHD; Phone Number: 00201206146539; Email: elhamramadan70@cu.edu.eg

Study Locations

• Egypt
  • Giza, Egypt, 02
    • Recruiting
    • Faculty of Physical Therapy
    • Contact: Elham S Hassan, PHD.; Phone Number: 00201206146539; Email: elhamramadan70@cu.edu.eg
    • Contact: Mohamed A Awad, PHD; Phone Number: 00201224955140; Email: awad18111972@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Experimental: 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).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh Sleep Quality Index	A reliable, validated, self-reported questionnaire for assessing sleep quality. It is available of validated Arabic form that consists of seven components, namely, subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over a 1-month time interval. It held a good internal consistency, and convergent, also divergent validity. Each component scores are derived, each scored 'zero' means no difficulty, to 'three' means sever difficulty. component scores are summed to gain the whole score range 'zero to twenty-one' Higher scores indicates worse sleep quality.	Pretreatment and immediately Posttreatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hot Flashes Questionnaire	A valid and reliable measure for severity of hot flashes. It is an appropriately sensitive tool to negative changes over time, with its cut-points and minimally important differences could prove a useful tool in targeting important issues regarding therapeutic interventions, and monitoring management progress and response using a 0 (do not interfere) to 10 (completely interfere) point scale. A total score is computed by summing items. Higher scores indicate higher interference due to hot flashes and thus, greater impact on quality of life.	Pretreatment and immediately Posttreatment.

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Walid M Zidan, PHD, Head and Professor of Obstetrics and Gynecology Department

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 20, 2024

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 11, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Skin Manifestations; Dyssomnias; Parasomnias; Flushing; Hot Flashes
• Other Study ID Numbers: REC/012/005081

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No