Heart FailureNCT04292665
Effects of Classical Massage and Benson Relaxation Exercise on Heart Failure Patients
A study testing Classical Massage and Benson Relaxation Exercise in people with Heart Failure and Symptoms and Signs, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Patients with heart failure will be entered. Participants will be randomized to one of three study arms: Arm 1: Classical massage, Arm 2: Relaxation, Arm 3: Control Hypothesis: Classical Massage and Benson Muscle Relaxation will decrease frequency, severity, discomfort of symptoms and improve quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Symptoms and Signs, Quality of Life
- What is being tested?
- Classical Massage and Benson Relaxation Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2019to 15 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Being at least primary school graduates,
- Being over 18 years old
- Being diagnosed Stage III-IV with heart failure
- Not using any other complementary or integrative therapy during the study period
Who cannot join
- Having an additional disease such as advanced stage chronic obstructive pulmonary disease, asthma, cancer
- Stage I-II diagnosed with heart failure
- Having an active thrombosis
- Having a coagulation problem
- Not volunteering to participate in the research
- Patients who have been hospitalized for 5 days or less and discharged before five days after the start of the application.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Medical Faculty Ibni Sina Hospital Cardiology Clinic
Ankara, 06100
About this study
Official title: Randomized Controlled Trial of Classical Massage and Benson Relaxation Exercise for Patients With Heart Failure
Patients with heart failure will be entered. Participants will be randomized to one of three study arms: Arm 1: Classical massage, Arm 2: Relaxation, Arm 3: Control Hypothesis: Classical Massage and Benson Muscle Relaxation will decrease frequency, severity, discomfort of symptoms and improve quality of life.
Read the detailed description
Previous reports have revealed that classical massage and Benson relaxation exercise are promising for physiological parameters such as respiratory rate, pulse, blood pressure in heart failure patients. On the other hand, research examining effects of these approaches on physical symptom status that is including dyspnea, orthopnea, fatigue, chest pain, peripheral edema, sleep problems and dizziness and quality of life is limited. The present study investigates the effects of classical massage and Benson relaxation exercise in a single-site, 3-arm, randomized, controlled study of 96 patients with heart failure. Arm 1: Classical massage; Arm 2: Benson relaxation exercise; Arm 3: Control. The investigators hypothesize that Classical Massage and Benson relaxation exercise will decrease frequency, severity, discomfort of symptoms and improve quality of life.
- Conditions
- Heart Failure, Symptoms and Signs, Quality of Life
- Being tested
- Classical Massage, Benson Relaxation Exercise, Control
- Keywords
- Classical massage,heart failure,nursing,relaxation
- Medical subject headings
- Heart Failure, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classical MassageBehavioural
During the first interview, a booklet explaining the introduction, purpose, benefits and application steps of hand-foot massage will be given to the patients in the classical massage group. Hand and foot massage will be applied to the patients for 30 minutes in the form of right hand five minutes, left hand five minutes, right foot ten minutes, left foot ten minutes, using liquid vaseline in each session twice a day in the patient's own bed with individual applied sessions by the researcher. Patients will receive a total of 14 sessions of classical massage, twice a day, for seven days.
Benson Relaxation ExerciseBehavioural
During the first interview, patients will be given a booklet explaining the description, purpose, benefits and application steps of the Benson relaxation exercise. With individual counseling sessions, a total of 14 sessions of Benson relaxation exercises will be performed in a quiet room, twice a day for seven days, each session lasting 20 minutes. At the beginning of the application, patients will focus on their breaths by taking slow and natural breaths with the researchers' commands and will quietly say to yourself the words of the focus, sound, sentence or prayer they choose, which are meaningful to them.
ControlOther
Patients will continue to receive standard nursing care and no further intervention will be made during the research.
| Study group | Role | What they receive |
|---|---|---|
| Classical Massage | Experimental | Patients will receive a total of fourteen individual applied classical massage sessions, twice daily for seven days, each session lasting 30 minutes. Receives: Behavioral: Classical Massage |
| Relaxation | Experimental | Patients will receive a total of fourteen individual counseling sessions, in a quiet room, twice daily for seven days, each session lasting 20 minutes. Receives: Behavioral: Benson Relaxation Exercise |
| Control | Other | Patients will continue to receive standard nursing care and no further intervention will be made during the research. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in symptom status
Symptom status will be measured based on patient report by the Symptom Status Questionnaire-Heart Failure . Higher score means increase in symptom burden.
Measured: Baseline measurements, at the end of 7th day and two weeks after the completion of the interventions
Change in quality of life
Quality of live will be measured by the Minnesota Living with Heart Failure Questionnaire. Higher scores on the scale mean worse quality of life.
Measured: Baseline measurements, at the end of 7th day and two weeks after the completion of the interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start15 Oct 2019
- Primary completion30 May 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Gulbahar, Hacettepe University
- Investigators
- Zehra Gok Metın, Assos.Prof., Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292665
- Status last verified
- Sep 2021
- First submitted
- 1 Mar 2020
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Classical Massage and Benson Relaxation Exercise for Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT04292665
- Conditions
- Heart Failure, Symptoms and Signs, Quality of Life
- Keywords
- Classical massage,heart failure,nursing,relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 3 Mar 2020 (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.
Patients with heart failure will be entered. Participants will be randomized to one of three study arms: Arm 1: Classical massage, Arm 2: Relaxation, Arm 3: Control Hypothesis: Classical Massage and Benson Muscle Relaxation will decrease frequency, severity, discomfort of symptoms and improve quality of life.
Detailed description
Previous reports have revealed that classical massage and Benson relaxation exercise are promising for physiological parameters such as respiratory rate, pulse, blood pressure in heart failure patients. On the other hand, research examining effects of these approaches on physical symptom status that is including dyspnea, orthopnea, fatigue, chest pain, peripheral edema, sleep problems and dizziness and quality of life is limited. The present study investigates the effects of classical massage and Benson relaxation exercise in a single-site, 3-arm, randomized, controlled study of 96 patients with heart failure. Arm 1: Classical massage; Arm 2: Benson relaxation exercise; Arm 3: Control. The investigators hypothesize that Classical Massage and Benson relaxation exercise will decrease frequency, severity, discomfort of symptoms and improve quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Classical Massage | Experimental | Behavioral: Classical MassagePatients will receive a total of fourteen individual applied classical massage sessions, twice daily for seven days, each session lasting 30 minutes. |
| Relaxation | Experimental | Behavioral: Benson Relaxation ExercisePatients will receive a total of fourteen individual counseling sessions, in a quiet room, twice daily for seven days, each session lasting 20 minutes. |
| Control | Other | Other: ControlPatients will continue to receive standard nursing care and no further intervention will be made during the research. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being at least primary school graduates,
- Being over 18 years old
- Being diagnosed Stage III-IV with heart failure
- Not using any other complementary or integrative therapy during the study period
Key exclusion criteria (6 listed)
- Having an additional disease such as advanced stage chronic obstructive pulmonary disease, asthma, cancer
- Stage I-II diagnosed with heart failure
- Having an active thrombosis
- Having a coagulation problem
- Not volunteering to participate in the research
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 |
|---|---|---|
| Classical MassageDuring the first interview, a booklet explaining the introduction, purpose, benefits and application steps of hand-foot massage will be given to the patients in the classical massage group. Hand and foot massage will be applied to the patients for 30 minutes in the form of right hand five minutes, left hand five minutes, right foot ten minutes, left foot ten minutes, using liquid vaseline in each session twice a day in the patient's own bed with individual applied sessions by the researcher. Patients will receive a total of 14 sessions of classical massage, twice a day, for seven days. | Behavioural | Classical Massage |
| Benson Relaxation ExerciseDuring the first interview, patients will be given a booklet explaining the description, purpose, benefits and application steps of the Benson relaxation exercise. With individual counseling sessions, a total of 14 sessions of Benson relaxation exercises will be performed in a quiet room, twice a day for seven days, each session lasting 20 minutes. At the beginning of the application, patients will focus on their breaths by taking slow and natural breaths with the researchers' commands and will quietly say to yourself the words of the focus, sound, sentence or prayer they choose, which are meaningful to them. | Behavioural | Relaxation |
| ControlPatients will continue to receive standard nursing care and no further intervention will be made during the research. | Other | Control |
Primary outcome
Change in symptom status
Time frame: Baseline measurements, at the end of 7th day and two weeks after the completion of the interventions
Symptom status will be measured based on patient report by the Symptom Status Questionnaire-Heart Failure . Higher score means increase in symptom burden.
Change in quality of life
Time frame: Baseline measurements, at the end of 7th day and two weeks after the completion of the interventions
Quality of live will be measured by the Minnesota Living with Heart Failure Questionnaire. Higher scores on the scale mean worse quality of life.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Zehra Gok Metın, Assos.Prof. study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Classical Massage and Benson Relaxation Exercise in people with Heart Failure and Symptoms and Signs, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in symptom status (time frame: Baseline measurements, at the end of 7th day and two weeks after the completion of the interventions). 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?
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 27 Sep 2021.