Acupressure to Improve Insomnia Among the Elderly With Hypertension

N/ANot Yet RecruitingNCT07827560

Phenikaa University94 enrolled

Overview

The goal of this study is to evaluate the feasibility and the effect of self-acupressure on improving insomnia among the elderly with hypertension who reported insomnia (using the Insomnia Severity Index questionnaire) The main questions it aims to answer are: * Is the proposed intervention feasible to deliver to the target population in terms of recruitment, retention, adherence, and completion of outcome assessments? * Does self-acupressure improve insomnia among the elderly with hypertension? Researchers will compare participants in the self-acupressure group (practice acupressure at home for 28 days) and the enhanced standard care group to see the effectiveness of acupressure in improving insomnia for hypertensive elderly individuals. Participants in the self-acupressure group will be instructed how to locate and perform acupressure, then they will be asked to practice acupressure at home for 28 days (once a day). Participants in the enhanced standard care group will receive training on how to apply sleep hygiene rules and will be asked to follow sleep hygiene rules for 28 days.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Insomnia (Self-reported, Non-diagnosed)Hypertension

Interventions

Acupressure to improve insomniaOTHER

The acupressure protocol of the intervention was developed and validated by 6 traditional and hypertensive experts. Participants will be ask to perform acupressure with 6 acupoint including: Baihui (GV20), Yintang (GV29), Shenmen (HT\&0\< Sanyinjao (SP6), Zushalin (ST36) at nightime (30 mins before going to bed) in 28 days.Each acupoint must be stimulated in 2 mins.

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Hypertention patient who are ≥ 60 years old * Having Insomnia Severity Index score ≥ 11 * Having Karnofsky score ≥ 80. Exclusion Criteria: * Patients who are currently participating in clinical trials for the treatment of insomnia. * Patients who are currently receiving pharmacological treatment for insomnia. * Patients with concomitant cardiovascular conditions, such as heart failure; patients with an implanted pacemaker; patients who have an indication for catheter-based cardiovascular intervention; or patients who have an indication for cardiovascular surgery. * Patients with psychiatric disorders, such as depression, generalized anxiety disorder, or bipolar disorder.

Outcomes

Primary Outcomes

Insomnia severity

The Insomnia Severity Index (ISI) is used to measure insomnia severity among participants. This instrument had been validated translated into Vietnamese previously and was being used in the cross-sectional study with high reliability (Cronbach's α = 0.92).

Time frame: Insomnia severity will be measured at 3 time points: Baseline, Week 4, and Week 8

Secondary Outcomes

Feasibiliy outcomes

\- The recruitment rate will be calculated based on the number of screened patients, the number of eligible patients, the number of eligible patients who finally agree to participate in the study, the number of patients who sign the informed consent form, the reasons for ineligibility and refusal, and the time to recruit enough participants will be recorded.

Time frame: The recruitment rate will be measured at baseline

Feasibility outcome

\- The acceptability score of the intervention will be measured by the Intervention Rating Profile (IRP-15), which consists of 15 Likert-type items; the sum of all 15 items ranges from 15 to 90. Higher overall scores indicate greater acceptability. A cutoff mean score (or average item score above 4.0) generally denotes that an intervention is perceived as acceptable and practical

Time frame: The acceptability score of the intervention will be measured at week 4

Feasibility outcome

The attrition rate will be calculated by the number of participants who decide to discontinue the study and the number of participants who are lost to follow-up during the study period. The attrition rate ranges from 0% to 100%, the higher lower attrition rate indicate the better feasible study is.

Time frame: Through study completion, an average of 1 year