Reflexology Versus Acupressure on Sleep Disturbance and Hot Flashes

NCT06499311 | Recruiting DMC

• 1 other identifier: REC/012/005081
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Postmenopausal Flushing; Hot Flashes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Hot Flashes Questionnaire

  Pretreatment and immediately Posttreatment.

Study Arms (2)

Group A; Foot Reflexology

EXPERIMENTAL

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

Group B; Acupressure

EXPERIMENTAL

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

Interventions

Foot Reflexology 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 A; Foot Reflexology

Acupressure 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.

Group B; Acupressure

Eligibility Criteria

• Age: 45 Years - 55 Years
• Gender Eligibility Details: The study targeting Postmenopausal women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Giza, 02, Egypt

RECRUITING

MeSH Terms

Conditions

Hot Flashes

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Walid M Zidan, PHD

  Head and Professor of Obstetrics and Gynecology Department

  STUDY CHAIR

Central Study Contacts

Dr Mohamed A Awad, PHD

CONTACT

00201224955140; awad18111972@yahoo.com

Elham S Hassan, PHD

CONTACT

00201206146539; elhamramadan70@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Each participant will have one identification number that will be used to assign participants into two equal groups in number (n=27), sequentially numbered index cards will be secured in opaque envelopes. Another assistant for the researcher will open the sealed envelope and will allocated the participants according to their groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist Specialist

Model Details: A prospective, randomized, controlled trial.

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 12, 2024
• Study Start: July 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 20, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

EG (1)