Acupressure to Improve Insomnia Among the Elderly With Hypertension
17 de septiembre de 2026 actualizado 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
94
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Huong Hoang, PhD
- Número de teléfono: +84 0982501850
- Correo electrónico: huong.hoangthixuan@phenikaa-uni.edu.vn
Ubicaciones de estudio
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Son Tay
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Hanoi, Son Tay, Vietnam, 100000
- Son Tay general hospital
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Contacto:
- Huong Hoang
- Número de teléfono: +84 0982501850
- Correo electrónico: huong.hoangthixuan@phenikaa-uni.edu.vn
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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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Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Insomnia severity
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibiliy outcomes
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
30 de agosto de 2026
Finalización primaria (Estimado)
30 de marzo de 2027
Finalización del estudio (Estimado)
30 de marzo de 2027
Fechas de registro del estudio
Enviado por primera vez
27 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de septiembre de 2026
Publicado por primera vez (Actual)
18 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PKA2
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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