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Acupressure for Insomnia (AcuSnooze)

2 février 2017 mis à jour par: Suzanna Zick, University of Michigan

Acupressure for Chronic Insomnia in Adults With Chronic Low Back Pain

The purpose of this study is to examine the effect of 6-weeks of relaxation acupressure compared to stimulating acupressure or a standard of care on sleep and daytime functioning. Also, to evaluate the ability of teaching acupressure using web-based applications.

It is believed that self-administered relaxation acupressure will result in improvements of sleep quality and quantity as compared to stimulating acupressure or a standard of care.

Aperçu de l'étude

Statut

Résilié

Les conditions

Intervention / Traitement

Description détaillée

Insomnia is a significant health problem and is associated with increased mental health issues: It is estimated that 9% to 15% of the adult population suffers from chronic insomnia. These estimates are considerably higher in primary care where from 20% to 33% suffer from chronic insomnia. Insomnia adversely affects psychological, physical and occupational functioning and places a significant burden on society. Moreover, several cohort studies have found that people with insomnia have significantly higher absenteeism at work, report poor self-esteem, less job satisfaction, and less efficiency at work compared to good sleepers.

Acupressure is a TCM technique based on a philosophy similar to that of acupuncture (the placement and stimulation of very fine needles into acupuncture points). Acupressure involves placing physical pressure by fingers, thumb, elbow, or with the aid of various devices such as pencil erasers on different acupuncture points (acupoints). Depending on the date of the review and the inclusion criteria, e.g., searched in Chinese language databases, there are anywhere from 7^12 to 4^68 randomized clinical trials (RCT) of various types of acupuncture (inclusive of acupressure) for treating insomnia. Regardless of the review the conclusions are remarkably consistent. Mainly, that the majority of RCTs demonstrated that acupuncture was significantly more effective than BDZs, sleep hygiene counseling, no treatment and sham acupuncture for treating insomnia.

The investigators will attempt to prove that self-administered Relaxation Acupressure (RA) will result in improvements in measures of sleep quality and quantity, compared to Stimulating Acupressure (SA) and a wait list control (WL). Also, that they will be able to teach the acupressure points using a web-based application.

Participants will be randomized into 1 of 3 arms; RA, SA, or WL (standard of care). If randomized into one of the acupressure arms, the participants will view their appropriate acupressure training lesson online and be tested on their understanding. They will also be asked to perform their acupoints once per day for a total of 6 weeks.

Type d'étude

Interventionnel

Inscription (Réel)

5

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Michigan
      • Ann Arbor, Michigan, États-Unis, 48105
        • Domino's Farm

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • 18-65 years of age
  • Meet DSM-IV criteria for primary insomnia
  • Insomnia must also be documented on two weeks of a baseline sleep diary

Exclusion Criteria:

  • Diagnosis or high clinical suspicion of a sleep disorder other than insomnia
  • Evidence of a unstable Axis I psychiatric disorder
  • Evidence of an uncontrolled medical disorder or pain syndrome that affects sleep, causes daytime sleepiness, or is likely to be causally associated with the insomnia
  • Current pharmacological or non-pharmacological insomnia treatment
  • Routine overnight shift work
  • Previous failed trial of acupuncture or acupressure

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: Standard of Care
Participants will be asked to continue doing whatever their healthcare providers advise for their insomnia, but not to start any new treatments during the study. They will also be given a sleep hygiene handout as a standard of care. After six weeks, they will be reassessed and then provided the opportunity to engage in the web-based acupressure intervention.
Comparateur actif: Relaxation Acupressure
In addition to being given a sleep hygiene handout as a standard of care, participants will be asked to apply pressure on each of following points (bilaterally where indicated). There are 5 acupoints with 4 of the acupoints performed on both the left and the right sides of the body giving a total of 9 points to stimulate. Each of the 9 acupoints will be stimulated for 3 minutes per point giving a total treatment time of 27 minutes done once daily.
Comportemental: Relaxation Acupressure
Apply pressure (stimulate) to the 9 acupoints for 3 minutes per point giving a total treatment time of 27 minutes done once daily for a period of 6 weeks.
Comparateur actif: Stimulating Acupressure
In addition to being given a sleep hygiene handout as a standard of care, participants will be asked to apply pressure on each of following points (bilaterally where indicated). There are 6 acupoints with 4 of the acupoints performed on both the left and the right sides of the body giving a total of 10 points to stimulate. Each of the 10 acupoints will be stimulated for 3 minutes per point giving a total treatment time of 30 minutes done once daily.
Comportemental: Stimulating Acupressure
Apply pressure (stimulate) to the 10 excitatory acupoints for 3 minutes per point giving a total treatment time of 30 minutes done once daily for a period of 6 weeks.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Difference in the effect of 6-weeks of Relaxation Acupressure compared to Stimulating Acupressure or standard of care on chronic insomnia and daytime functioning.
Délai: 6 weeks

Insomnia will be assessed/determined by daily sleep/wake diaries and the Insomnia Severity Index questionnaire. Sleep Diary: insomnia = <85% sleep efficiency ratio.

Daytime functioning will be determined by the Fatigue Severity Scale of Sleep Disorders (FSS).
6 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Success of teaching the acupressure interventions using a novel web-based application measured by an Acupressure Fidelity Form at week 1 and week 6.
Délai: 6 weeks
The success of learning acupressure via a web-based application will be assessed using an Acupressure Fidelity Form. The form will assess the participants ability to locate each acupressure point, demonstrate proper pressure/technique, and know the frequency of their treatments. Acupressure Form A is worth a total of 12 points while Form B is worth 13 points. Each correct answer is worth 1 point. We will consider our web based intervention "successful" if 95% of participants (49 of them) received a score of 100% at both visits.
6 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Michigan

Les enquêteurs

  • Chercheur principal: Suzanna M Zick, ND, MPH, , Department of Family Medicine, University of Michigan
  • Chercheur principal: Richard E Harris, PhD, , Departments of Anesthesiology and Internal Medicine, University of Michigan

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

15 juin 2011

Achèvement primaire (Réel)

15 décembre 2013

Achèvement de l'étude (Réel)

15 décembre 2013

Dates d'inscription aux études

Première soumission

16 juin 2011

Première soumission répondant aux critères de contrôle qualité

20 juin 2011

Première publication (Estimation)

22 juin 2011

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

6 février 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 février 2017

Dernière vérification

1 février 2017

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • OVPR-235500

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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