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BMJ Open. 2017 Aug 11;7(8):e016269. doi: 10.1136/bmjopen-2017-016269.

Electroacupuncture for treating insomnia in patients with cancer: a study protocol for a randomised pilot clinical trial.

Author information

1
Clinical Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.
2
Department of Neuropsychiatry, College of Oriental Medicine, Dong-eui University, Busan, Republic of Korea.
3
Department of Internal Medicine, College of Traditional Korean Medicine, Daejeon University, Daejeon, Republic of Korea.

Abstract

INTRODUCTION:

Although insomnia is one of the most prevalent and disturbing symptoms among patients with cancer, it has not been properly managed. Electroacupuncture (EA) has received attention as a promising intervention for insomnia, and a few previous studies have reported that this intervention may be beneficial for treating insomnia in patients with cancer. The aim of this pilot study is to explore the feasibility and preliminary effectiveness of EA on the sleep disturbance of patients with cancer with insomnia using a subjective method, patient-reported questionnaires and an objective tool, actigraphy, to measure the quality of sleep.

METHODS AND ANALYSIS:

This is a study protocol for a randomised, three-arm, multicentre, pilot clinical trial. A total of 45 patients with cancer who have continuous insomnia related to cancer treatment or cancer itself will be randomly allocated to an EA group, sham EA group or usual care group in equal proportions. The EA group will receive 10 sessions of EA treatment over 4 weeks. The sham EA group will receive sham EA at non-acupoints using non-penetrating Streitberger acupuncture needles with mock EA. The usual care group will not receive EA treatment. All participants will be provided a brochure on the management of sleep disorders regardless of their group assignment. The primary outcome measure is the mean change in the insomnia severity index from the baseline to week 5. Information related to sleep quality will also be obtained through the Pittsburgh Sleep Quality Index, a sleep diary and actigraphy. Participants will complete the trial by visiting the research centre at week 9 for follow-up assessment.

ETHICS AND DISSEMINATION:

This study protocol was approved by the institutional review boards of each research centre. Written informed consent will be obtained from all participants. The result of this study will be published in peer-reviewed journals or presented at academic conferences.

TRIAL REGISTRATION NUMBER:

KCT0002162; Pre-results.

KEYWORDS:

cancer; electroacupuncture; insomnia; randomised controlled trial; sleep disturbance

PMID:
28801421
PMCID:
PMC5629657
DOI:
10.1136/bmjopen-2017-016269
[Indexed for MEDLINE]
Free PMC Article

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