Mindfulness meditation on blood pressure and quality of life in patients with intradialytic hypertension
| ISRCTN | ISRCTN82788940 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82788940 |
- Submission date
- 23/10/2024
- Registration date
- 29/10/2024
- Last edited
- 28/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
This study aims to observe the effects of mindfulness meditation on blood pressure changes and quality of life in hypertensive patients suffering from intradialytic hypertension (IDH) during hemodialysis.
Who can participate?
Patients aged 18 years or older with maintenance hemodialysis and IDH
What does the study involve?
The control group received routine care (hemodialysis and health education), while the intervention group received mindfulness meditation in addition to routine care. Blood pressure and quality of life changes were evaluated at enrollment and three months post-intervention.
What are the possible benefits and risks of participating?
Mindfulness meditation may improve blood pressure during dialysis and enhance patients' quality of life.
The intervention group may experience inauthentic self-perceptions and increased sensory perceptual sensitivity.
Where is the study run from?
Blood Purification Center of Lihuili Hospital in Ningbo City
When is the study starting and how long is it expected to run for?
May 2023 to November 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Jiang Liu, liujiang_2024@126.com
Contact information
Public, Scientific, Principal Investigator
No. 1111, Jiangnan Road, Yinzhou District
Ningbo
315099
China
| Phone | +86 13429286446 |
|---|---|
| liujiang_2024@126.com |
Study information
| Study design | Single-center interventional double-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life, Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Mindfulness meditation on blood pressure and quality of life in patients with intradialytic hypertension during hemodialysis |
| Study hypothesis | Mindfulness meditation may improve blood pressure during dialysis and enhance patients' quality of life. |
| Ethics approval(s) |
Approved 14/08/2023, Ethics Review Committee of Lihuili Hospital in Ningbo City (No. 57, Xingning Road, Yinzhou District, Ningbo, 315040, China; +86 0574 87018834; lihuiliethics@163.com), ref: KY2023PJ204 |
| Condition | Blood pressure control and recovery in hemodialysis patients |
| Intervention | The patients are randomly assigned to an intervention group and a control group using a random number table. The control group received standard antihypertensive drug treatment and routine care (including hemodialysis and health education), while the intervention group additionally received mindfulness meditation intervention. The intervention was 3 times a week, about 63 minutes each time, for a total of 12 weeks, including: 1.Observe the body (15 minutes); 2.Observe the breathing (5 minutes); 3.Dialysis visualization (5 minutes); 4.Sound wave therapy (30 minutes); 5.Stress release (8 minutes), a total of 5 parts (total 63 minutes). After the intervention, the subjects’ experiences and problems encountered during meditation are discussed in the group through the WeChat platform, and medical staff will provide relevant answers and guidance. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Blood pressure measured using the blood pressure monitoring module on the dialysis machine before dialysis, at 1, 2, and 3 hours during dialysis, and after dialysis 2. Quality of life measured using the Kidney Disease and Treatment-related Quality of Life (KDTA) and the general health-related quality of life (SF-36) scales before and 12 weeks after the intervention |
| Secondary outcome measures | Fasting venous blood was collected from the elbow to measure hemoglobin (Hb), inflammation markers (IL-6, CRP), nutritional indicators (ALB), homocysteine (Hcy), Parathyroid hormone (PTH) and dialysis adequacy (KT/V) before and 12 weeks after the intervention. 1. Hb measured using advanced photoelectric detector 2. CRP measured using chemiluminescence 3. IL-6 measured using enzyme-linked immunosorbent assay (ELISA). 4. ALB measured using ultraviolet spectrophotometer 5. HCY measured using radioenzyme assay 6. PTH measured using fluorescent immunochromatography |
| Overall study start date | 25/05/2023 |
| Overall study end date | 16/11/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 69 |
| Total final enrolment | 69 |
| Participant inclusion criteria | 1. Meeting the diagnostic criteria for hypertension during dialysis, that is, the blood pressure increased by more than 15 mmHg during dialysis 2. Aged between 18 and 75 years old, with good overall health status 3. Demonstrating good treatment compliance and being able to actively cooperate with the doctor's treatment and guidance 4. The weekly dialysis time was 9 - 12 hours, the KT/V value was at least 1.2, and the hemoglobin (Hb) level was between 10 - 13 g/dL 5. Being able to accurately measure blood pressure in the upper limbs |
| Participant exclusion criteria | 1. Patients whose blood pressure could only be measured in the lower limbs 2. Patients with mental disorders or other diseases that affected their cooperation in the study 3. Patients with other serious diseases that might affect the study results |
| Recruitment start date | 02/07/2023 |
| Recruitment end date | 14/08/2023 |
Locations
Countries of recruitment
- China
Study participating centre
Ningbo
315099
China
Sponsor information
Hospital/treatment centre
No. 57, Xingning Road, Yinzhou District
Ningbo
315040
China
| Phone | +86 0574 87018701 |
|---|---|
| lhl2290@mail.nbptt.zj.cn | |
| Website | http://www.nblhlyy.com/ |
"ROR" |
https://ror.org/030zcqn97 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 16/11/2024 |
|---|---|
| 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 during and/or analysed during the current study are/will be available upon request from the corresponding author, Jiang Liu, liujiang_2024@126.com. |
Editorial Notes
28/10/2024: Trial's existence confirmed by Ethics Review Committee of Lihuili Hospital in Ningbo City.
