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NCT Number: NCT06499311

Reflexology Versus Acupressure on Sleep Disturbance and Hot Flashes

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.

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Key information

Conditions

Postmenopausal Flushing Hot Flashes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

45 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Pittsburgh Sleep Quality Index

    Time frame: Pretreatment and immediately Posttreatment.

    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.

Secondary outcomes

  1. Hot Flashes Questionnaire

    Time frame: Pretreatment and immediately Posttreatment.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Mohamed A Awad, PHD

CONTACT

[email protected]

00201224955140

Elham S Hassan, PHD

CONTACT

[email protected]

00201206146539

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 12, 2024
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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