Acupressure to Improve Insomnia Among the Elderly With Hypertension
17 de setembro de 2026 atualizado por: Hoang T.X Huong, Phenikaa University
Self-acupressure to Improve Insomnia Among the Elderly With Hypertension: a Randomized Controlled Trial
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.
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
94
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Huong Hoang, PhD
- Número de telefone: +84 0982501850
- E-mail: huong.hoangthixuan@phenikaa-uni.edu.vn
Locais de estudo
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Son Tay
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Hanoi, Son Tay, Vietnã, 100000
- Son Tay general hospital
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Contato:
- Huong Hoang
- Número de telefone: +84 0982501850
- E-mail: huong.hoangthixuan@phenikaa-uni.edu.vn
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Acupressure group
Participants will receive a self-acupressure training section and requested to practice acupressure at home once a day at night time (before going to bed) for four weeks. During that time, participants will receive a weekly phone call follow up from researchers. By the end of week fourth, participants will be requested to complete post-intervention assessment. A short-term follow up will be then carried out in 4 weeks. By the end of follow up time, participants will be asked to complete post follow up assessement and received 200.000 vnd (12 usd) as complimentary. The acupressure protocol of the intervention was developed and validated by 6 traditional and hypertensive experts. |
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.
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Sem intervenção: Control group
Participants in the control group will receive a training session on sleep hygiene rules and will be ask to practice thoes rule in 28 days.
Weekly telephone reminder will also be made in four week.
By the end of week fourth, participants in this group will be requested to complete post-intervention assessment.
A short-term follow up will be then carried out in 4 weeks.
During the follow-up period, participants receive no weekly telephone reminder.
By the end of follow up time, researchers will make a telephone reminder to participants and ask them to complete and send back all the follow-up assessment questionnaire.
200,000 vnd (equal to 12 usd) will be given to participants for complymentary
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Insomnia severity
Prazo: Insomnia severity will be measured at 3 time points: Baseline, Week 4, and Week 8
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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).
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Insomnia severity will be measured at 3 time points: Baseline, Week 4, and Week 8
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Feasibiliy outcomes
Prazo: The recruitment rate will be measured at baseline
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- 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.
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The recruitment rate will be measured at baseline
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Feasibility outcome
Prazo: The acceptability score of the intervention will be measured at week 4
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- 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
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The acceptability score of the intervention will be measured at week 4
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Feasibility outcome
Prazo: Through study completion, an average of 1 year
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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.
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Through study completion, an average of 1 year
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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Publicações Gerais
- Hmwe NTT, Browne G, Mollart L, Allanson V, Chan SW. Acupressure to improve sleep quality of older people in residential aged care: a randomised controlled trial protocol. Trials. 2020 Apr 25;21(1):360. doi: 10.1186/s13063-020-04286-2.
- Zhang J, Zhou X, Jiang H, Zhu W, Chi H, Jiang L, Zhang S, Yang J, Deng S, Li B, Zhuo B, Zhang M, Cao B, Meng Z. Acupuncture for insomnia symptoms in hypertensive patients: a systematic review and meta-analysis. Front Neurol. 2024 Feb 19;15:1329132. doi: 10.3389/fneur.2024.1329132. eCollection 2024.
- Uchmanowicz I, Markiewicz K, Uchmanowicz B, Koltuniuk A, Rosinczuk J. The relationship between sleep disturbances and quality of life in elderly patients with hypertension. Clin Interv Aging. 2019 Jan 15;14:155-165. doi: 10.2147/CIA.S188499. eCollection 2019.
- Yazdanpanahi Z, Ghaemmaghami M, Akbarzadeh M, Zare N, Azisi A. Comparison of the Effects of Dry Cupping and Acupressure at Acupuncture Point (BL23) on the Women with Postpartum Low Back Pain (PLBP) Based on Short Form McGill Pain Questionnaires in Iran: A Randomized Controlled Trial. J Family Reprod Health. 2017 Jun;11(2):82-89.
- Wang XQ, Qin S, Wu WZ, Liu CY, Shang HT, Wan QY, Zhao YN, Xi HQ, Zheng SY, Li JH, Wang Y. [Effect of electroacupuncture on serum melatonin and dopamine in aged insomnia]. Zhongguo Zhen Jiu. 2021 May 12;41(5):501-4. doi: 10.13703/j.0255-2930.20200404-k0001. Chinese.
- Lu G, Chen F, Guo C, Wu J. Acupuncture for senile insomnia: A systematic review of acupuncture point. Arch Gerontol Geriatr. 2024 Dec;127:105586. doi: 10.1016/j.archger.2024.105586. Epub 2024 Jul 27.
- Yao L, Liu Y, Li M, Zheng H, Sun M, He M, Zhong Z, Ma S, Huang H, Wang H. The central regulatory effects of acupuncture in treating primary insomnia: a review. Front Neurol. 2024 Dec 10;15:1406485. doi: 10.3389/fneur.2024.1406485. eCollection 2024.
- Wang Y, Jiang HL, Zhao JY, Liu NN, Yi L, Yang ZR, Zhao SM, Wang FC. Efficacy of multiple acupoint stimulation therapies for primary insomnia patients: a systematic review and network meta-analysis. Front Psychiatry. 2026 Apr 13;17:1678631. doi: 10.3389/fpsyt.2026.1678631. eCollection 2026.
- Yu XS, Liu YM, Pan W, Wang XY, Lin LN, Shen QY, Zhang H, Zheng SY, Nie N, Jin B, Liang Y, Liu YJ, Fang JQ. Acupoint Sensitivity in Patients with Primary Insomnia and Its Correlation with Polysomnography and Heart Rate Variability: A Cross-Sectional Study. Nat Sci Sleep. 2026 Mar 4;18:567428. doi: 10.2147/NSS.S567428. eCollection 2026.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
30 de agosto de 2026
Conclusão Primária (Estimado)
30 de março de 2027
Conclusão do estudo (Estimado)
30 de março de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
27 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
17 de setembro de 2026
Primeira postagem (Real)
18 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
18 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
17 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PKA2
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
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Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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