The effect of mindfulness meditation on sleep quality and negative emotions in stroke patients with heart disease
| ISRCTN | ISRCTN15770131 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15770131 |
| Secondary identifying numbers | 2022 Hebei Province Medical Science Research Project number: 20221008 |
- Submission date
- 20/06/2024
- Registration date
- 24/06/2024
- Last edited
- 24/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Sleep is one of the most fundamental and essential physiological needs for humans. It plays a crucial role in the recovery of the body, the integration and consolidation of memory, and is an indispensable component of health. Neuroscientific research indicates that sleep is a state required for maintaining highly physiological functions, adaptive behaviors, and biological defense mechanisms. Sleep significantly affects both physical and mental health, as well as the onset and progression of various diseases. Mindfulness meditation, as an emerging non-pharmacological therapy, has garnered considerable research attention in the field of insomnia in recent years and is considered an effective adjunctive method for improving sleep. This study aims to observe the effects of combining oral eszopiclone with mindfulness meditation on insomnia in stroke patients with concurrent coronary heart disease through a prospective randomized controlled clinical trial, in hopes of providing a more advantageous reference for rehabilitation treatment of such patients in clinical settings.
Who can participate?
Stroke patients with concurrent coronary heart disease whose sleep quality and negative emotions are currently affected
What does the study involve?
Participants will be randomly allocated to two groups that will receive routine treatment, including medication therapy and conventional rehabilitation training. Medication Therapy includes antiplatelet medication, lipid-lowering and plaque-stabilization medication, blood glucose control, blood pressure management, and neurotrophic medication. Conventional Rehabilitation Training: this is tailored according to the functional impairments of the patients and includes limb motor function training in stroke patients, activities of daily living (ADL) training, and related physical therapies.
For the control group, in addition to the standard treatment, eszopiclone tablets (Disha Pharmaceutical Group Co., Ltd., approval number H20213830, 3 mg/tablet) will be administered orally before bedtime, at a dosage of 3mg once daily.
In the intervention group, mindfulness meditation training is added to the treatment regimen based on the control group's therapy. The intervention is divided into three stages, with the mindfulness meditation protocol developed according to relevant literature.
What are the possible benefits and risks of participating?
Mindfulness meditation can effectively improve sleep quality and reduce negative emotions in stroke patients with concurrent coronary heart disease, as well as promote the recovery of limb functions. There is little evidence about the potential harmful effects of mindfulness meditation. But caution is needed.
Where is the study run from?
The Second Hospital of Hebei Medical University
When is the study starting and how long is it expected to run for?
May 2021 to April 2024
Who is funding the study?
Health Commission of Hebei Province 2022 Hebei Province Medical Science Research Project
Who is the main contact?
Guangxiao Ni, kll51x6g4@163.com
Contact information
Public, Scientific, Principal Investigator
The first Department of Rehabilitation, the Second Hospital of Hebei Medical University
No. 215 Heping West Road, Xinhua District
Shijiazhuang City
050000
China
 ORCID ID |
0009-0007-1984-3875 |
|---|---|
| Phone | +86 15230161010 |
| kll51x6g4@163.com |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Efficacy of mindfulness meditation on sleep quality and negative emotions in stroke patients with concurrent coronary heart disease |
| Study acronym | Effect of Mindfulness Meditation on Stroke Patient |
| Study hypothesis | To investigate the efficacy of mindfulness meditation on sleep quality and negative emotions in stroke patients with concurrent coronary heart disease. |
| Ethics approval(s) |
Approved 20/05/2021, Research Ethics Committee of The Second Hospital of Hebei Medical University (No. 215 Heping West Road, Xinhua District, Shijiazhuang City, 050051, China; +86 66002811; kll51x6g4@163.com), ref: 2021-R296 |
| Condition | Sleep quality and negative emotions in stroke patients with concurrent coronary heart disease |
| Intervention | Eligible stroke patients with concurrent coronary heart disease at the Second Hospital of Hebei Medical University will be selected. The patients will be randomly divided into an intervention group and a control group. The control group will receive routine treatment plus eszopiclone tablets, while the intervention group will receive mindfulness meditation in addition to the treatment given to the control group. Routine treatment included medication therapy and conventional rehabilitation training. Medication Therapy included: This included antiplatelet medication, lipid-lowering and plaque-stabilization medication, blood glucose control, blood pressure management, and neurotrophic medication. Conventional Rehabilitation Training: This was tailored according to the functional impairments of the patients and included limb motor function training in stroke patients, activities of daily living (ADL) training, and related physical therapies. For the control group, in addition to the standard treatment, eszopiclone tablets (Disha Pharmaceutical Group Co., Ltd., approval number H20213830, 3 mg/tablet) were administered orally before bedtime, at a dosage of 3mg once daily. In the observation group, mindfulness meditation training was added to the treatment regimen based on the control group's therapy. The intervention was divided into three stages, with the mindfulness meditation protocol developed according to relevant literature. 1. Introduction Stage (Week 1) 2. Maintenance Stage (Week 2) 3. Consolidation Stage (Weeks 3 to 6) Participating patients were required to practice mindfulness meditation for 45 minutes each night before bed, record the time and their feelings after completing the practice, and continue this training for 6 weeks, with focused feedback and Q&A sessions in a WeChat group every Sunday. After 6 weeks of treatment, participants from both groups were to gradually reduce and then cease using eszopiclone within a maximum of 2 weeks. Data will be collected before the intervention, and/or after 6 and 12 weeks of the intervention, including general information, Pittsburgh Sleep Quality Index (PSQI), Self-Rating Anxiety Scale (SAS) scores, Self-Rating Depression Scale (SDS) scores, and Fugl-Meyer Assessment (FMA) scores. Demographic data comprises gender, age, BMI, disease duration, education level, stroke location, stroke region, marital status, place of residence, limb disability, hypertension, diabetes, and per capita monthly income. The PSQI will be used to assess the patient's sleep quality. The total score ranges from 0 to 21, with scores >7 indicating sleep disturbances. The higher the score, the poorer the sleep quality. The SDS and SAS were used to evaluate the visitor's depression and anxiety levels. An SDS score > 72 indicates severe depression; an SDS score of 63-72 suggests moderate depression; an SDS score of 53-62 indicates mild depression; an SDS score <53 signifies the absence of depression. A SAS score >69 denotes severe anxiety that requires immediate referral to a professional psychology institution; a SAS score of 60-69 indicates moderate anxiety, with the testee often feeling anxious recently, yet generally able to self-regulate; a SAS score of 50-59 suggests mild anxiety, with occasional anxious experiences recently, but with minor symptoms that usually quickly resolve after timely adjustment; a SAS score <50 signifies the absence of anxiety, considered a normal state. Motor function will be assessed using the FMA, including the Upper Limb Motor Function Assessment (comprising 33 items, with a total score of 66) and the Lower Limb Motor Function Assessment (comprising 17 items, with a total score of 34). A higher score indicates better motor function of the affected limb. |
| Intervention type | Mixed |
| Primary outcome measure | The following primary outcome measures will be assessed before the intervention, and/or after 6 and 12 weeks of the intervention: 1. Sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI) 2. Anxiety measured using the Self-Rating Anxiety Scale (SAS) 3. Depression measured using Self-Rating Depression Scale (SDS) 4. Motor function measured using the Fugl-Meyer Assessment (FMA) |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 05/05/2021 |
| Overall study end date | 30/04/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 72 |
| Total final enrolment | 72 |
| Participant inclusion criteria | 1. First onset of ischemic stroke confirmed via imaging, with a prior clear diagnosis of concurrent coronary heart disease 2. Presence of insomnia that appeared either after the stroke or within one month before the stroke onset, with a Pittsburgh Sleep Quality Index (PSQI) score of ≥ 7 3. Self-Rating Anxiety Scale (SAS) score of ≥ 50 and Self-Rating Depression Scale (SDS) score of ≥ 53 4. Clear consciousness, normal cognitive function, and ability to cooperate with treatment 5. Voluntary signing of informed consent by the patient and their family for participation in this trial |
| Participant exclusion criteria | 1. Aphasia, abnormal mental behavior post-AIS, or severe consciousness disorders 2. Existence of unstable angina or myocardial infarction within the past two weeks 3. Significant organ dysfunction 4. Patients with malignant tumors 5. Existence of sleep disorders for more than one month before the stroke onset, or sleep disorders caused by medications or other systemic diseases 6. History of allergy to eszopiclone or similar medications |
| Recruitment start date | 01/05/2023 |
| Recruitment end date | 20/04/2024 |
Locations
Countries of recruitment
- China
Study participating centre
Shijiazhuang City
050000
China
Sponsor information
Hospital/treatment centre
No. 215 Heping West Road, Xinhua District
Shijiazhuang City
050000
China
| Phone | +86 311-66002999 |
|---|---|
| pub@hb2h.com | |
| Website | http://www.hb2h.com/ |
"ROR" |
https://ror.org/015ycqv20 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Hebei Provincial Health Commission, 河北省卫生健康委员会
- Location
- China
Results and Publications
| Intention to publish date | 31/01/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be available upon request from Guangxiao Ni (kll51x6g4@163.com) |
Editorial Notes
20/06/2024: Study's existence confirmed by the Research Ethics Committee of The Second Hospital of Hebei Medical University.
