Palliative Care, Health ServicesNCT07904611
Integrating Rhythmical Massage in Palliative Care
A study testing Rhythmic Massage in people with Palliative Care, Health Services and Palliative Care, run by Monash University Malaysia.
Trial summary
People receiving palliative and end-of-life care may experience pain, fatigue, sleep difficulties, anxiety, and other symptoms that affect their comfort and quality of life. While standard medical treatments are important, additional supportive approaches may help promote comfort and wellbeing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care, Health Services, Palliative Care, Massage Intervention
- What is being tested?
- Rhythmic Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2027to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals receiving palliative or end-of-life care at a participating community hospice.
- Individuals clinically appropriate to receive Rhythmical Massage (RM), as determined by the treating healthcare professional.
- Individuals able to read and understand the study information and provide written informed consent.
Who cannot join
- Individuals whose clinical condition or other circumstances make receiving RM inappropriate or potentially cause undue discomfort, as assessed by the treating healthcare professional and RM practitioner.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluating and Integrating Rhythmical Massage Into Palliative and End-of-Life Care in Malaysia: A Mixed-Methods Study
People receiving palliative and end-of-life care may experience pain, fatigue, sleep difficulties, anxiety, and other symptoms that affect their comfort and quality of life. While standard medical treatments are important, additional supportive approaches may help promote comfort and wellbeing.
Rhythmical Massage (RM) is a gentle, non-invasive touch-based approach involving rhythmic movements, light touch, warmth, and rest. However, there is limited evidence on its use in palliative care in Malaysia.
This research will evaluate RM using quantitative measures of symptom burden, pain intensity, sleep quality, and physiological responses among people receiving palliative and end-of-life care in a community hospice. RM will be provided alongside, and will not replace, usual medical and palliative care. The findings will provide locally relevant evidence on the potential benefits, safety, experiences, and practical considerations of using RM as a complementary supportive approach in Malaysian palliative care.
- Being tested
- Rhythmic Massage
- Keywords
- Rhythmical massage, Palliative care, End-of-Life Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythmic MassageOther
Rhythmical Massage (RM) is a gentle, non-invasive, touch-based approach involving rhythmic movements, light pressure, warmth, and a period of rest following each session. In this study, participants will receive approximately 4-6 RM sessions over 2-3 weeks, administered by trained RM practitioners.
| Study group | Role | What they receive |
|---|---|---|
| Adults receiving palliative or end-of-life care at a community hospice | Experimental | Not described Receives: Other: Rhythmic Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Symptom Burden
Change in symptom burden measured using the Edmonton Symptom Assessment System (ESAS), which assesses the severity of symptoms experienced by people receiving palliative care.
Measured: Baseline (before the first RM session) to the end of the intervention period (approximately 2-3 weeks).
Change in Pain Intensity
Change in pain intensity measured using a Visual Analogue Scale (VAS), with participants rating their pain intensity on a scale from 0 (no pain) to 10 (worst imaginable pain).
Measured: Before and immediately after each Rhythmical Massage (RM) session, across approximately 4-6 sessions over 2-3 weeks.
Secondary outcomes (2)
Change in Sleep Quality
Change in sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI), which assesses sleep quality and sleep disturbances.
Measured: Baseline to the end of the intervention period (approximately 2-3 weeks).
Change in Heart Rate Variability (HRV)
Changes in heart rate variability, including high-frequency (HF) power and the standard deviation of normal-to-normal intervals (SDNN), measured to assess changes in autonomic cardiac activity associated with Rhythmical Massage (RM).
Measured: Immediately before and after each RM session, across approximately 4-6 sessions over 2-3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Feb 2027 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Palliative Care, Health ServicesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-group study in which all participants receive Rhythmical Massage (RM) alongside their usual medical and palliative care. Clinical outcomes and selected physiological measures are assessed before and after RM sessions. No randomization or allocation to separate study groups is involved.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monash University Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teoh Siew Li, Monash University Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904611
- Sponsor's protocol ID
- 54142
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon request via direct contact to researcher
Publications
Walchli C, Saltzwedel G, Kruerke D, Kaufmann C, Schnorr B, Rist L, Eberhard J, Decker M, Simoes-Wust AP. Physiologic effects of rhythmical massage: a prospective exploratory cohort study. J Altern Complement Med. 2014 Jun;20(6):507-15. doi: 10.1089/acm.2012.0833. Epub 2013 May 23.
PubMed 23700977Werthmann PG, Cysarz D, Jungbluth M, Lederer AK, Nenova G, Huber R, van Dijk M, Kienle GS. Efficacy and safety of massage for postoperative stress in colorectal cancer patients: a randomized, controlled, three-arm trial. Front Oncol. 2025 Feb 5;15:1439420. doi: 10.3389/fonc.2025.1439420. eCollection 2025.
PubMed 39980553
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating and Integrating Rhythmical Massage Into Palliative and End-of-Life Care in Malaysia: A Mixed-Methods Study
- ClinicalTrials.gov ID
- NCT07904611
- Acronym / sponsor ID
- 54142
- Keywords
- Rhythmical massage, Palliative care, End-of-Life Care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Monash University MalaysiaUniversity, hospital or other
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People receiving palliative and end-of-life care may experience pain, fatigue, sleep difficulties, anxiety, and other symptoms that affect their comfort and quality of life. While standard medical treatments are important, additional supportive approaches may help promote comfort and wellbeing.
Rhythmical Massage (RM) is a gentle, non-invasive touch-based approach involving rhythmic movements, light touch, warmth, and rest. However, there is limited evidence on its use in palliative care in Malaysia.
This research will evaluate RM using quantitative measures of symptom burden, pain intensity, sleep quality, and physiological responses among people receiving palliative and end-of-life care in a community hospice. RM will be provided alongside, and will not replace, usual medical and palliative care. The findings will provide locally relevant evidence on the potential benefits, safety, experiences, and practical considerations of using RM as a complementary supportive approach in Malaysian palliative care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-group study in which all participants receive Rhythmical Massage (RM) alongside their usual medical and palliative care. Clinical outcomes and selected physiological measures are assessed before and after RM sessions. No randomization or allocation to separate study groups is involved.
| Arm | Type | Receives |
|---|---|---|
| Adults receiving palliative or end-of-life care at a community hospice | Experimental | Other: Rhythmic Massage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals receiving palliative or end-of-life care at a participating community hospice.
- Individuals clinically appropriate to receive Rhythmical Massage (RM), as determined by the treating healthcare professional.
- Individuals able to read and understand the study information and provide written informed consent.
Key exclusion criteria (1 listed)
- Individuals whose clinical condition or other circumstances make receiving RM inappropriate or potentially cause undue discomfort, as assessed by the treating healthcare professional and RM practitioner.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhythmic MassageRhythmical Massage (RM) is a gentle, non-invasive, touch-based approach involving rhythmic movements, light pressure, warmth, and a period of rest following each session. In this study, participants will receive approximately 4-6 RM sessions over 2-3 weeks, administered by trained RM practitioners. | Other | Adults receiving palliative or end-of-life care at a community hospice |
Primary outcome
Change in Symptom Burden
Time frame: Baseline (before the first RM session) to the end of the intervention period (approximately 2-3 weeks).
Change in symptom burden measured using the Edmonton Symptom Assessment System (ESAS), which assesses the severity of symptoms experienced by people receiving palliative care.
Change in Pain Intensity
Time frame: Before and immediately after each Rhythmical Massage (RM) session, across approximately 4-6 sessions over 2-3 weeks.
Change in pain intensity measured using a Visual Analogue Scale (VAS), with participants rating their pain intensity on a scale from 0 (no pain) to 10 (worst imaginable pain).
2 secondary outcomes
Change in Sleep Quality
Time frame: Baseline to the end of the intervention period (approximately 2-3 weeks).
Change in Heart Rate Variability (HRV)
Time frame: Immediately before and after each RM session, across approximately 4-6 sessions over 2-3 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 23700977Walchli C, Saltzwedel G, Kruerke D, Kaufmann C, Schnorr B, Rist L, Eberhard J, Decker M, Simoes-Wust AP. Physiologic effects of rhythmical massage: a prospective exploratory cohort study. J Altern Complement Med. 2014 Jun;20(6):507-15. doi: 10.1089/acm.2012.0833. Epub 2013 May 23.
- Background: PubMed 39980553Werthmann PG, Cysarz D, Jungbluth M, Lederer AK, Nenova G, Huber R, van Dijk M, Kienle GS. Efficacy and safety of massage for postoperative stress in colorectal cancer patients: a randomized, controlled, three-arm trial. Front Oncol. 2025 Feb 5;15:1439420. doi: 10.3389/fonc.2025.1439420. eCollection 2025.
- Individual participant dataSharing planned: No. Upon request via direct contact to researcher
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Rhythmic Massage in people with Palliative Care, Health Services and Palliative Care, run by Monash University Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Siew Li Teoh (+6012-3223273, teoh.siew.li@monash.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Symptom Burden (time frame: Baseline (before the first RM session) to the end of the intervention period (approximately 2-3 weeks).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07904611, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.