Acupressure to Improve Insomnia Among the Elderly With Hypertension
17 settembre 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
94
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Huong Hoang, PhD
- Numero di telefono: +84 0982501850
- Email: huong.hoangthixuan@phenikaa-uni.edu.vn
Luoghi di studio
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Son Tay
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Hanoi, Son Tay, Vietnam, 100000
- Son Tay general hospital
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Contatto:
- Huong Hoang
- Numero di telefono: +84 0982501850
- Email: huong.hoangthixuan@phenikaa-uni.edu.vn
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Nessun intervento: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Insomnia severity
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Feasibiliy outcomes
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
30 agosto 2026
Completamento primario (Stimato)
30 marzo 2027
Completamento dello studio (Stimato)
30 marzo 2027
Date di iscrizione allo studio
Primo inviato
27 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
17 settembre 2026
Primo Inserito (Effettivo)
18 settembre 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
18 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
17 settembre 2026
Ultimo verificato
1 settembre 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PKA2
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .