High blood pressure in pregnancy: the effect of mechanical massage with electrical massage chair on reducing blood pressure
| ISRCTN | ISRCTN85430789 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85430789 |
- Submission date
- 12/02/2025
- Registration date
- 12/02/2025
- Last edited
- 12/02/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English Summary
Background and study aims
High blood pressure disorder during in pregnancy (HDP) account for about 14% of all maternal deaths worldwide with 18.1 million new cases of HDP estimated to occur in 2019. HDP is a leading cause of the death of babies including stillbirths, malformations in babies, poor baby growth during pregnancy, very low birth weight and very premature birth. Current management strategies for HDP focus on blood pressure control using medications and timely delivery.
Manual massage by hand can lower blood pressure in the short term. In non-pregnant populations, a 15-minute moderate pressure chair massage session results in unconscious changes to the nervous system toward a setting favouring the lowering of blood pressure during the massage. The immediate effect of mechanical massage using an automated electric massage chair to lower blood pressure in pregnancies affected by high blood pressure is not known.
This study plans to evaluate if a 30-minute massage session of the back portion of the head, neck, shoulders, torso, buttocks and limbs using the electric massage chair compared to just sitting comfortably on the massage chair without the massage function activated for 30 minutes can lower blood pressure in the 4-hours immediately after the session in hospitalised pregnant women with high blood pressure in addition to the best of standard care high blood pressure treatment.
Who can participate?
Hospitalised adult women of 20 weeks pregnant with high blood pressure who are not anticipated to need delivery within the next 24 hours.
What does the study involve?
All participants are expected to spend two 30-minute session on the electric massage chair. The sessions will be 4 hours apart.
In one group, the session will start with the massage function activated followed 4 hours later by a second session when the massage function will be inactivated. In the other group, the order is reversed; first session massage function inactivated, and second session massage function activated. Group assignment of participants will be performed by computer.
Immediately before, and immediately, 1, 2, and 4 hours after each session the participants blood pressure and pulse will be measured using an automated blood pressure monitor. In the 4 hours between the chair sessions, participants will receive standard care and allowed the usual ward activities. Standard clinical care always applies.
What are the possible benefits and risks of participating?
Mechanical massage by the electric chair may temporarily lower blood pressure demonstrating its potential for use an additional treatment method for high blood pressure in pregnancy. For this short-term study, no major benefit is anticipated.
The mechanical massage may be perceived to be uncomfortable and this discomfort may cause your blood pressure to temporarily increase. Participants are instructed that they can change the massage setting or to stop the massage at any time and for any reason. For this short-term study, no major harm is anticipated.
Where is the study run from?
The Department of Obstetrics & Gynaecology, Universiti Malaya.
When is the study starting and how long is it expected to run for?
September 2024 to December 2025
Who is funding the study?
The Department of Obstetrics & Gynaecology, Universiti Malaya.
Who is the main contact?
Dr Nadia Azia Binti Aziz, drnaa219@yahoo.com
Contact information
Public, Scientific, Principal Investigator
University Malaya Medical Center
Kuala Lumpur
59100
Malaysia
| Phone | +60 136336735 |
|---|---|
| nadiaazia@ummc.edu.my |
Public, Scientific
Department of Obstetric and Gynaecology
University Malaya Medical Center
Kuala Lumpur
59100
Malaysia
 ORCID ID |
0000-0001-8713-6581 |
|---|---|
| Phone | +60 379492059 |
| pctan@um.edu.my |
Public, Scientific
Department of Obstetric and Gynaecology
University Malaya Medical Center
Kuala Lumour
59100
Malaysia
| Phone | +60 379492059 |
|---|---|
| nvalli@um.edu.my |
Public, Scientific
Department of Obstetric and Gynaecology
University Malaya Medical Center
Kuala Lumpur
59100
Malaysia
| Phone | +60 379492473 |
|---|---|
| thai.wong@um.edu.my |
Study information
| Study design | Randomized counterbalanced crossover placebo-controlled |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Efficacy |
| Participant information sheet | 46834 PIS 10May 2024.pdf |
| Scientific title | Mechanical massage with an electrical massage chair on blood pressure in hypertensive disorders in pregnancy: a randomised counterbalanced cross-over trial |
| Study hypothesis | Mechanical massage with an electric massage chair rapidly reduces blood pressure in hypertensive disorder in pregnancy. |
| Ethics approval(s) |
Approved 25/09/2024, University of Malaya Medical Centre Medical Research Ethics Committee (University Malaya Medical Center, Lembah Pantai, 59100, Malaysia; +60 379498473; ummcmrec@ummc.edu.my), ref: 2024715-13920 |
| Condition | Hypertensive disorder in pregnancy |
| Intervention | Randomisation will be conducted by opening a numbered, sealed, opaque envelope, with the lowest numbered envelope available assigned to the latest recruit. The randomization sequence will be generated in random blocks of 4 or 8 (1:1 ratio) using https://www.sealedenvelope.com/simple-randomiser/v1/lists by a co-investigator who will not be involved in trial recruitment. Participants will be allocated to one of two trial arms: Arm 1: ON-MASSAGE followed by OFF-MASSAGE after a 6-hour gap OR Arm 2: OFF-MASSAGE followed by ON-MASSAGE after a 6-hour gap. Massage Chair Intervention (ON-MASSAGE): Participants will receive a session of automated mechanical massage on the massage chair (involving the neck, posterior shoulders, and back). The intervention will consist of a 30-minute massage session delivered once only. Participants will have the option to adjust the massage intensity according to their preference and select the massage chair's incline for their comfort. During the session, participants will be seated comfortably on the massage chair, and the massage program will be initiated. Participants will vacate the massage chair after the 30-minute session and return to their usual inpatient activity. The massage program can be terminated at any time by a participant by pressing a button on the control panel – this activity will be shown to participants and their understanding will be actively demonstrated before starting the massage session. Blood pressure and heart rate measurements will be taken before the session, immediately after the session, and at 1-, 2-, and 4-hours post-session. Control Intervention (OFF-MASSAGE): Participants will sit on the massage chair without activating the massage function. They will spend 30 minutes on the chair but will not receive any massage therapy as a ‘placebo’ control, similarly, delivered once only. Participants will have the option to select the massage chair's incline for their comfort. During the session, participants will be seated comfortably on the massage chair, but no active massage program will be initiated. Participants will vacate the massage chair after the 30-minute session and return to their usual inpatient activity. Blood pressure and heart rate measurements will be taken before the session, immediately after the session, and at 1-, 2-, and 4-hours post-session. The sequence of interventions will be counterbalanced by one-to-one randomisation, with one arm starting with ON-MASSAGE followed by OFF-MASSAGE, while the other arm will begin with OFF-MASSAGE followed by ON-MASSAGE. There will be a 6-hour interval between the sessions for washout, to reduce any immediate or very short-term carry-over effects from the first session. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Electric massage chairs (automated) |
| Primary outcome measure | Immediate systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arterial blood pressure (MAP - calculated using the formula MAP = DBP + 1/3[SBP – DBP]) values and change, measured using an automated blood pressure machine at the end of the ON or OFF sessions for each participant |
| Secondary outcome measures | 1. SBP, DBP, MAP, and HR are measured using an automated blood pressure machine at 1, 2, and 4 hours after each massage chair session 2. Maternal satisfaction is measured using a 0-10 numerical rating scale immediately after completion of each session 3. Change to anti-hypertensive medications is measured using patient records within the next 24 hours 4. Eclampsia observed within 6 hours of massage chair session 5. Clinical placental abruption observed within 6 hours of massage chair session |
| Overall study start date | 25/09/2024 |
| Overall study end date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Female |
| Target number of participants | 110 |
| Participant inclusion criteria | 1. Admission to antenatal ward 2. Diagnosis of hypertensive disorder in pregnancy: prior systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥90 mmHg on at least 2 occasions, at least 4 hours apart during pregnancy 3. Gestational age ≥20 weeks 4. Age ≥18 years 5. Able to consent |
| Participant exclusion criteria | 1. Contraindication to massage therapy 2. Severe complications necessitating immediate medical intervention (e.g. imminent delivery, hypertensive crisis, magnesium sulphate therapy) |
| Recruitment start date | 17/02/2025 |
| Recruitment end date | 17/08/2025 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
59100
Malaysia
Sponsor information
University/education
Obstetric and Gynaecology Department
Lembah Pantai
Kuala Lumpur
59100
Malaysia
| Phone | +60 379492049 |
|---|---|
| kj_obg@ummc.edu.my | |
| Website | https://medicine.um.edu.my/obstetrics-amp-gynaecology-department |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/05/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high- impact peer reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Prof Tan Peng Chiong, pctan@um.edu.my subject to institutional review board approval |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 10/05/2024 | 12/02/2025 | No | Yes |
Additional files
Editorial Notes
12/02/2025: Trial's existence confirmed by University of Malaya Medical Centre Medical Research Ethics Committee.
