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Acupressure to Improve Insomnia Among the Elderly With Hypertension

17. september 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

94

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: Acupressure to improve insomnia
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.
Ingen inngripen: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Insomnia severity
Tidsramme: Insomnia severity will be measured at 3 time points: Baseline, Week 4, and Week 8
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).
Insomnia severity will be measured at 3 time points: Baseline, Week 4, and Week 8

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Feasibiliy outcomes
Tidsramme: The recruitment rate will be measured at baseline
- 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.
The recruitment rate will be measured at baseline
Feasibility outcome
Tidsramme: The acceptability score of the intervention will be measured at week 4
- 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
The acceptability score of the intervention will be measured at week 4
Feasibility outcome
Tidsramme: Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Phenikaa University

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

30. august 2026

Primær fullføring (Antatt)

30. mars 2027

Studiet fullført (Antatt)

30. mars 2027

Datoer for studieregistrering

Først innsendt

27. august 2026

Først innsendt som oppfylte QC-kriteriene

17. september 2026

Først lagt ut (Faktiske)

18. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PKA2

Plan for individuelle deltakerdata (IPD)

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NEI

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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