OBJECTIVE: To assess the feasibility of patient recruitment and retention, logistics of intervention and outcome measure sensitivity for a study designed to investigate the use of acupuncture and reflexology for the management of insomnia. DESIGN: Feasibility study for a randomised controlled trial. SETTING: University of Ulster Clinic. PATIENTS: Thirteen participants with sleep disturbances. INTERVENTIONS: Participants were randomised to receive one of three treatments, either: acupuncture (n = 5), reflexology (n = 4) or music therapy (n = 4). These treatments were administered six times over a 3-week period. MAIN OUTCOME MEASURES: The Pittsburgh Sleep Quality Index (PSQI) and Short Form 36 version 2 (SF-36v2) were recorded at baseline, post-treatment and follow-up. Each participant also completed a Sleep Diary. RESULTS: Ten participants completed treatment. In the acupuncture and reflexology groups, a clinically relevant improvement in two out of three participants was observed on the PSQI following treatment. Music therapy produced no clinically important improvements. This study has demonstrated the feasibility of conducting an RCT on the effect of acupuncture and reflexology in primary insomnia using PSQI as the primary outcome measure. Modifications for a more rigorous study design have been discussed. Results from such a study would address the lack of high-quality evidence for the effectiveness of such therapies.
RCT Entities:
OBJECTIVE: To assess the feasibility of patient recruitment and retention, logistics of intervention and outcome measure sensitivity for a study designed to investigate the use of acupuncture and reflexology for the management of insomnia. DESIGN: Feasibility study for a randomised controlled trial. SETTING: University of Ulster Clinic. PATIENTS: Thirteen participants with sleep disturbances. INTERVENTIONS:Participants were randomised to receive one of three treatments, either: acupuncture (n = 5), reflexology (n = 4) or music therapy (n = 4). These treatments were administered six times over a 3-week period. MAIN OUTCOME MEASURES: The Pittsburgh Sleep Quality Index (PSQI) and Short Form 36 version 2 (SF-36v2) were recorded at baseline, post-treatment and follow-up. Each participant also completed a Sleep Diary. RESULTS: Ten participants completed treatment. In the acupuncture and reflexology groups, a clinically relevant improvement in two out of three participants was observed on the PSQI following treatment. Music therapy produced no clinically important improvements. This study has demonstrated the feasibility of conducting an RCT on the effect of acupuncture and reflexology in primary insomnia using PSQI as the primary outcome measure. Modifications for a more rigorous study design have been discussed. Results from such a study would address the lack of high-quality evidence for the effectiveness of such therapies.
Authors: Nicholas Hargrove; Nada El Tobgy; Olivia Zhou; Mark Pinder; Brittany Plant; Nicole Askin; Laura Bieber; David Collister; Reid Whitlock; Navdeep Tangri; Clara Bohm Journal: Clin J Am Soc Nephrol Date: 2021-03-25 Impact factor: 8.237