PainNCT05428644
Effect of Reflexology Massage on Pain and Anxiety.
A study testing massage therapy in people with Pain and Anxiety, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
Aim: The aim of this study is to examine the effects of reflexology hand massage group and placebo group on pain and anxiety in patients undergoing coronary artery bypass graft surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- massage therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2022to 10 Oct 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be over 18 years of age,
- To know Turkish and to agree to participate in the research
- No previous open heart surgery
- Non-urgent planned bypass surgery
- Without any intra-aortic balloon pump or pacemaker
- Not taking inotropic drugs
Show all 9Show fewer
- Patients who have no problem to apply massage; Those who do not have any skin lesions, burns
- Extubated
- Not taking analgesics
Who cannot join
- Mitral valve repair or replacement during CABG surgery
- Those who have any skin lesions, burns, open wounds, muscle and bone-related pathological disease, phlebitis
- Not disconnected from mechanical ventilation
- Having a risk factor for complications (e.g: ejection fraction < 35%)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Massage on Patients Undergoing Coronary Artery Bypass Graft Surgery
Aim: The aim of this study is to examine the effects of reflexology hand massage group and placebo group on pain and anxiety in patients undergoing coronary artery bypass graft surgery.
Method: Individuals who have undergone coronary artery bypass graft surgery in accordance with the sampling inclusion criteria will be allocated to the reflexology and placebo groups by block randomization using the randomization method. After the groups are determined, the patients in the reflexology hand massage group and placebo group will be asked to fill in the Socio-Demographic Information Form, the State Anxiety Scale and the Visual Analog Scale will be taken.
In addition to the standard nursing care of the hospital, individuals in the reflexology group and placebo group will be massaged for 10 minutes, a total of 20 minutes, after the extubation procedure. Individuals in the reflexology group and placebo group will be followed up before the massage (0. minute) and after the massage at the 5th, 30th and 60th minutes, and the data will be recorded.
Read the detailed description
Pain and anxiety are common postoperative problems that impair recovery and quality of life in patients undergoing coronary artery bypass graft (CABG) surgery. These problems cause changes in physiological parameters, prolonged recovery, sleep problems and a decrease in quality of life in patients. Hand reflexology, which is among the non-pharmacological methods, is an effective intervention that nurses can apply independently in the management of pain and anxiety.Therefore, this study aimed to examine the effect of reflexology on pain and anxiety.
- Being tested
- massage therapy
- Keywords
- hand reflexology, nursing care, pain management
- Medical subject headings
- Pain, Anxiety Disorders, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massage therapyBehavioural
In addition to the standard nursing care of the hospital, individuals in the reflexology hand massage and placebo hand massage group will be given a 10-minute massage for both hands, a total of 20 minutes, after the extubation procedure.
| Study group | Role | What they receive |
|---|---|---|
| reflexology hand massage group | Active comparator | In addition to the standard nursing care of the hospital, individuals in the reflexology hand massage will be given a 10-minute massage for both hands, a total of 20 minutes, after the extubation procedure. Receives: Behavioral: massage therapy |
| placebo hand massage group | Placebo comparator | In addition to the standard nursing care of the hospital, individuals in the placebo hand massage group will be given a 10-minute massage for both hands, a total of 20 minutes, after the extubation procedure. Receives: Behavioral: massage therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain scores of reflexology hand massage and placebo hand massage group
Comparison of pain scores between reflexology hand massage and placebo hand massage groups. The patients' pain score data were collected by the Visual Analog Scale. It is a 10-point scale. Higher points show a higher level of pain.
Measured: Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up before the massage.
pain scores of reflexology hand massage and placebo hand massage group
Comparison of pain scores between reflexology hand massage and placebo hand massage groups. The patients' pain score data were collected by the Visual Analog Scale. It is a 10-point scale. Higher points show a higher level of pain.
Measured: Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up 5th minute after the massage.
pain scores of reflexology hand massage and placebo hand massage group
Comparison of pain scores between reflexology hand massage and placebo hand massage groups. The patients' pain score data were collected by the Visual Analog Scale. It is a 10-point scale. Higher points show a higher level of pain.
Measured: Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up 30th minute after the massage.
pain scores of reflexology hand massage and placebo hand massage group
Comparison of pain scores between reflexology hand massage and placebo hand massage groups. The patients' pain score data were collected by the Visual Analog Scale. It is a 10-point scale. Higher points show a higher level of pain.
Measured: Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up 60th minute after the massage.
Secondary outcomes (2)
anxiety scores of reflexology hand massage and placebo hand massage group
Comparison of anxiety scores between reflexology hand massage and placebo hand massage groups. The patients' anxiety score data were collected by the State Anxiety Inventory. It is a 20-item scale. The scores in the inventory range from 20 to 80. Higher points show a higher level of anxiety.
Measured: Individuals in the reflexology hand massage and placebo hand massage groups will be followed up before the massage.
anxiety scores of reflexology hand massage and placebo hand massage group
Comparison of anxiety scores between reflexology hand massage and placebo hand massage groups. The patients' anxiety score data were collected by the State Anxiety Inventory. It is a 20-item scale. The scores in the inventory range from 20 to 80. Higher points show a higher level of anxiety.
Measured: Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up 60th minute after the massage.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start10 Feb 2022
- Primary completion15 Sep 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double-blind randomised controlled clinical trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gizem Göktuna, Dokuz Eylul University
- Investigators
- Gülşah Gürol Arslan, PhD, Principal investigator, Associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428644
- Sponsor's protocol ID
- 2021/04-24 08.02.2021
- Status last verified
- Nov 2022
- First submitted
- 23 Mar 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Massage on Patients Undergoing Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT05428644
- Acronym / sponsor ID
- 2021/04-24 08.02.2021
- Keywords
- hand reflexology, nursing care, pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 23 Jun 2022 (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.
Aim: The aim of this study is to examine the effects of reflexology hand massage group and placebo group on pain and anxiety in patients undergoing coronary artery bypass graft surgery.
Method: Individuals who have undergone coronary artery bypass graft surgery in accordance with the sampling inclusion criteria will be allocated to the reflexology and placebo groups by block randomization using the randomization method. After the groups are determined, the patients in the reflexology hand massage group and placebo group will be asked to fill in the Socio-Demographic Information Form, the State Anxiety Scale and the Visual Analog Scale will be taken.
In addition to the standard nursing care of the hospital, individuals in the reflexology group and placebo group will be massaged for 10 minutes, a total of 20 minutes, after the extubation procedure. Individuals in the reflexology group and placebo group will be followed up before the massage (0. minute) and after the massage at the 5th, 30th and 60th minutes, and the data will be recorded.
Detailed description
Pain and anxiety are common postoperative problems that impair recovery and quality of life in patients undergoing coronary artery bypass graft (CABG) surgery. These problems cause changes in physiological parameters, prolonged recovery, sleep problems and a decrease in quality of life in patients. Hand reflexology, which is among the non-pharmacological methods, is an effective intervention that nurses can apply independently in the management of pain and anxiety.Therefore, this study aimed to examine the effect of reflexology on pain and anxiety.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A double-blind randomised controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| reflexology hand massage group | Active comparator | Behavioral: massage therapyIn addition to the standard nursing care of the hospital, individuals in the reflexology hand massage will be given a 10-minute massage for both hands, a total of 20 minutes, after the extubation procedure. |
| placebo hand massage group | Placebo comparator | Behavioral: massage therapyIn addition to the standard nursing care of the hospital, individuals in the placebo hand massage group will be given a 10-minute massage for both hands, a total of 20 minutes, after the extubation procedure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- To be over 18 years of age,
- To know Turkish and to agree to participate in the research
- No previous open heart surgery
- Non-urgent planned bypass surgery
- Without any intra-aortic balloon pump or pacemaker
Key exclusion criteria (4 listed)
- Mitral valve repair or replacement during CABG surgery
- Those who have any skin lesions, burns, open wounds, muscle and bone-related pathological disease, phlebitis
- Not disconnected from mechanical ventilation
- Having a risk factor for complications (e.g: ejection fraction < 35%)
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 |
|---|---|---|
| massage therapyIn addition to the standard nursing care of the hospital, individuals in the reflexology hand massage and placebo hand massage group will be given a 10-minute massage for both hands, a total of 20 minutes, after the extubation procedure. | Behavioural | placebo hand massage group, reflexology hand massage group |
Primary outcome
pain scores of reflexology hand massage and placebo hand massage group
Time frame: Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up before the massage.
Comparison of pain scores between reflexology hand massage and placebo hand massage groups. The patients' pain score data were collected by the Visual Analog Scale. It is a 10-point scale. Higher points show a higher level of pain.
pain scores of reflexology hand massage and placebo hand massage group
Time frame: Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up 5th minute after the massage.
Comparison of pain scores between reflexology hand massage and placebo hand massage groups. The patients' pain score data were collected by the Visual Analog Scale. It is a 10-point scale. Higher points show a higher level of pain.
pain scores of reflexology hand massage and placebo hand massage group
Time frame: Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up 30th minute after the massage.
Comparison of pain scores between reflexology hand massage and placebo hand massage groups. The patients' pain score data were collected by the Visual Analog Scale. It is a 10-point scale. Higher points show a higher level of pain.
pain scores of reflexology hand massage and placebo hand massage group
Time frame: Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up 60th minute after the massage.
Comparison of pain scores between reflexology hand massage and placebo hand massage groups. The patients' pain score data were collected by the Visual Analog Scale. It is a 10-point scale. Higher points show a higher level of pain.
2 secondary outcomes
anxiety scores of reflexology hand massage and placebo hand massage group
Time frame: Individuals in the reflexology hand massage and placebo hand massage groups will be followed up before the massage.
anxiety scores of reflexology hand massage and placebo hand massage group
Time frame: Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up 60th minute after the massage.
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 15 Nov 2022.
- 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.
Gülşah Gürol Arslan, PhD principal investigator
Associate professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing massage therapy in people with Pain and Anxiety, run by Dokuz Eylul 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 9 inclusion and 4 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 15 Nov 2022. 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. Some participants in this study may receive a placebo. 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?
pain scores of reflexology hand massage and placebo hand massage group (time frame: Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up before the massage.). The study lists 4 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 15 Nov 2022.