Effect of the Reflexology on Insomnia Severity Index in Hypertensive Patients

Not Applicable

Completed

• Conditions: Hypertension

• Registration Number: NCT06315764
• Lead Sponsor: Cairo University

Brief Summary

In Egypt, there is a dearth of understanding of the benefits of reflexology and aerobic exercise on hypertension patients' quality of life.

Detailed Description

The participated subjects were enrolled based on the inclusion and exclusion criteria , In this study, forty hypertensive female patients between 35 and 45 were divided to two equal groups (A and B). Twenty female patients in group (A) got medications and peddling training, while twenty female patients in group (B) had the exact treatment as group (A) as well as reflexology. Insomina severity index and a short form 36 quality of life questionnaire were used to assess the patients who took part in the study (ISI). They were assessed before and after the eight-week treatment program, which consisted of three sessions each week; following four weeks of treatment (post-1) and additional four weeks of treatment (post-2) the post evaluation was used (post-2).

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-01-30
• Study Completion: 2023-05-30
• Status Verified: 2024-03
• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-11
• Last Update Submitted: 2024-03-11
• Study First Posted: 2024-03-18
• Last Update Posted: 2024-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

1. Forty hypertensive patients aged 35 to 45 years of both sexes (men and women).
2. Clinical and medically, all of the participants were in good health.
3. The BMI ranged from 30 to 34.9 kg/m2 for all participants.

Exclusion Criteria

1. Close Myocardial infarcts.
2. Heart block or complex ventricular arrhythmia
3. Cerebrovascular disease is a condition in which the blood vessels in the brain become inflamed.
4. Defects in vision or hearing.
5. Significant tightness in the lower limbs and/or a fixed deformity of lower limbs.
6. Balance or mentality-related neurological diseases (e.g. epilepsy).
7. Abnormalities of lower limb that may be congenital or acquired.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Blood pressure measurements:	four weeks then four weeks( eight weeks)	it consisted of systolic blood pressure which measures the pressure in arteries when heart beats and diastolic blood pressure which measures the pressure in arteries when heart rests between beats.
Insomnia severity index	four weeks then four weeks( eight weeks)	The Insomnia severity index is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. The usual recall period is the "last month" and the dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, notice ability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem),; Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe) The higher score is the worse outcome.
Short form 36 quality of life questionnaire (SF-36):	four weeks then four weeks( eight weeks)	it is used for measuring health-related quality of life (HRQL) which consists of 36 questions (SF-36) (limitations on physical functioning because of health problems), it was done personal interviewing using Arabic version

Trial Locations

Locations (1)

Heba Mousa; 🇪🇬 Cairo, Egypt