閉経周辺期女性の不眠症に対する自己指圧 (SAP)
閉経周辺期女性の不眠症に対する自己指圧：パイロットランダム化比較試験
Insomnia is a common complaint in peri-menopausal women. Acupressure might be a potential way to treat insomnia. Although acupressure can be self-administered, it is uncertain that whether the effects of self-administered acupressure are comparable to that of the practitioner-administered acupressure, due to the variability in patients' capability of mastering the acupressure technique and self-compliance. Previous studies seemingly suggested that self-administered acupressure may improve sleep quality, their conclusion on the efficacy of self-administered acupressure for insomnia was limited due to the lack of standardized subjective and objective sleep assessments and unclear diagnostic method of insomnia. To fill out this research gap, the proposed study will explore the effectiveness of self-acupressure for improving sleep in perimenopasual women using an RCT approach.
調査の概要
詳細な説明
Insomnia is a common complaint in peri-menopausal women, with approximately one-third to half of the women aged 40-55 years suffering from insomnia. A recent clinical study indicated that the microbial composition in insomnia patients was different from healthy controls, and the immune factors and metabolic pathways could mediate the relationship between gut microbes and insomnia. However, such linkage needs more studies to verify.
Acupressure is a treatment modality in traditional Chinese medicine (TCM), in which the practitioner stimulates patient's acupoints using fingers, hands, or elbows according to TCM meridian theory.
Instead of practitioner-administered, the patients can be trained and perform acupressure on themselves. Such self-administered acupressure is less time-intensive and flexible to perform. Once the patient has learned the technique, self-administered acupressure does not cost anything, hence constitutes the lowest financial burden.
Although acupressure can be self-administered, it is uncertain that whether the effects of self-administered acupressure are comparable to that of the practitioner-administered acupressure, due to the variability in patients' capability of mastering the acupressure technique and self-compliance. Previous studies seemingly suggested that self-administered acupressure may improve sleep quality, their conclusion on the efficacy of self-administered acupressure for insomnia was limited due to the lack of standardized subjective and objective sleep assessments and unclear diagnostic method of insomnia. To fill out this research gap, the proposed study will explore the effectiveness of self-acupressure for improving sleep in perimenopasual women using an RCT approach.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Hong Kong、香港
- School of Nursing, the Hong Kong Polytechnic University
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
The inclusion criteria were as follows: (i) Chinese Hong Kong residents who were able to read Chinese; (ii) age 35 to 64 years; (iii) peri-menopausal women, defined as menstrual cycle irregularity (a change of 7 days or more in the menstrual cycle) or amenorrhea for no longer than 60 consecutive days, according to the recommendations from the Stages of Reproductive Aging Workshop; and (iv) with a current clinical DSM-5 diagnosis of insomnia disorder according to the Brief Insomnia Questionnaire. The criteria included having difficulties falling asleep, staying asleep, or early morning awakening with clinically significant consequences for daily life for at least 3 months. (v) An Insomnia Severity Index total score of at least 10 indicated that insomnia was present at the clinical level and (vi) Able to understand Chinese and Cantonese or Mandarin; (vii) willing to give informed consent and comply with the trial protocol.
For (iv) and (v), both the Brief Insomnia Questionnaire and Insomnia Severity Index were included as inclusion criteria. This is because the two scales have different purposes. Specifically, Brief Insomnia Questionnaire is used to confirm the participants fulfil the diagnostic criteria of DSM-5 insomnia disorder, while the Insomnia Severity Index is used to assess the severity of the insomnia symptoms and related daytime impairments.
The exclusion criteria are: (i) pregnancy; (ii) at significant suicide risk according to the rating by the Hamilton Depression Rating Scale item on suicide (score ≥3); (iii) no comorbid sleep disorders primarily requiring other treatments, such as sleep apnea or narcolepsy; (iv) change in the dose of their psychotropic drugs within 12 weeks prior to baseline, which would possibly indicate instability in their psychiatric condition; and (v) taking any antibiotics in 3 months before the baseline or any food containing probiotics, such as yogurt, in 7 days before the baseline.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Self-acupressure group
Subjects will attend two weekly 120-minute of self-administered acupressure training according to the group allocation in a classroom at the School Nursing, the Hong Kong Polytechnic University. The subjects will be trained to perform self-administered acupressure by an acupuncturist. To enhance interaction and ensure the quality of teaching, each class will be conducted in a small group of 5 to 7 subjects. Participants in this group will learn the self-acupressure technique and passed fidelity check. The treatment protocol included 6 acupoints, namely, Baihui (GV20) and bilateral Fenchi (GB20), Neiguan (PC6), Shenmen (HT7), Shenxu (BL23) and Yongquan (KI1) (Table 1). Subjects were given an acupressure log to record their practice at home, and they were phoned twice a week to remind their practice during the 4-week treatment period. |
Subjects will attend two weekly 120-minute of self-administered acupressure training according to the group allocation in a classroom at the School Nursing, the Hong Kong Polytechnic University. The subjects will be trained to perform self-administered acupressure by an acupuncturist. To enhance interaction and ensure the quality of teaching, each class will be conducted in a small group of 5 to 7 subjects. Participants in this group will learn the self-acupressure technique and passed fidelity check. The treatment protocol included 6 acupoints, namely, Baihui (GV20) and bilateral Fenchi (GB20), Neiguan (PC6), Shenmen (HT7), Shenxu (BL23) and Yongquan (KI1) (Table 1). Subjects were given an acupressure log to record their practice at home, and they were phoned twice a week to remind their practice during the 4-week treatment period.
他の名前：
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アクティブコンパレータ：Sleep Hygiene Education group
The participants in this group will receive education on sleep hygiene. The treatment duration, frequency, and telephone follow-up schedule for the SHE group will be the same as the self-administered acupressure group (2 sessions, 2 hours each). Sleep hygiene education is often used as a comparison group in randomized controlled trials of self-help and psychological interventions for insomnia. The SHE group will provide subjects with the same amount of contact hours with the healthcare professional (instructor) in order to control the non-specific effects of practitioner-patient interaction in the self-administered acupressure group. |
The participants in this group will receive education on sleep hygiene. The treatment duration, frequency, and telephone follow-up schedule for the SHE group will be the same as the self-administered acupressure group (2 sessions, 2 hours each). Sleep hygiene education is often used as a comparison group in randomized controlled trials of self-help and psychological interventions for insomnia. The SHE group will provide subjects with the same amount of contact hours with the healthcare professional (instructor) in order to control the non-specific effects of practitioner-patient interaction in the self-administered acupressure group.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Insomnia Severity Index
時間枠：Baseline
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The Insomnia Severity Index has 7 items that measured the severity of insomnia complaints and related daytime impairments. The total score ranges between 0 and 28, with the higher scores indicating more severe insomnia. |
Baseline
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Insomnia Severity Index
時間枠：Week 2
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The Insomnia Severity Index has 7 items that measured the severity of insomnia complaints and related daytime impairments. The total score ranges between 0 and 28, with the higher scores indicating more severe insomnia. |
Week 2
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Insomnia Severity Index
時間枠：Week 4
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The Insomnia Severity Index has 7 items that measured the severity of insomnia complaints and related daytime impairments. The total score ranges between 0 and 28, with the higher scores indicating more severe insomnia. |
Week 4
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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A 7-day sleep diary
時間枠：Measued one-week before the assessment time point.
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the subjects will be asked to record their daily sleeping-waking schedule using a standard sleep diary for 7 days, and Sleep parameters, such as sleep onset latency (SOL), wake after sleep onset (WASO), sleep efficiency (SE), and sleep duration (TST) will be measured. |
Measued one-week before the assessment time point.
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Hospital Anxiety and Depression Scale
時間枠：Baseline
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The Hospital Anxiety and Depression Scale is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). |
Baseline
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Hospital Anxiety and Depression Scale
時間枠：Week 2
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The Hospital Anxiety and Depression Scale is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). |
Week 2
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Hospital Anxiety and Depression Scale
時間枠：Week 4
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The Hospital Anxiety and Depression Scale is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). |
Week 4
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Microbiota
時間枠：Baseline
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16s rRNA sequencing of gut microbiota of the current study will be performed. The stool samples will be collected using commercially available kits. The kit contains a 5 ml buffer tube. The stool sample should be soaked in the buffer, therefore about 2-3 g stool will be collected. The kits will rapidly homogenize and stabilize the samples at the point-of-collection and transport and store stabilized DNA at ambient temperature for at least one month-no cold chain required. |
Baseline
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Microbiota
時間枠：Week 2
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16s rRNA sequencing of gut microbiota of the current study will be performed. The stool samples will be collected using commercially available kits. The kit contains a 5 ml buffer tube. The stool sample should be soaked in the buffer, therefore about 2-3 g stool will be collected. The kits will rapidly homogenize and stabilize the samples at the point-of-collection and transport and store stabilized DNA at ambient temperature for at least one month-no cold chain required. |
Week 2
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Microbiota
時間枠：Week 4
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16s rRNA sequencing of gut microbiota of the current study will be performed. The stool samples will be collected using commercially available kits. The kit contains a 5 ml buffer tube. The stool sample should be soaked in the buffer, therefore about 2-3 g stool will be collected. The kits will rapidly homogenize and stabilize the samples at the point-of-collection and transport and store stabilized DNA at ambient temperature for at least one month-no cold chain required. |
Week 4
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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