Myocardial InfarctionNCT06007716
The Effect Of Reflexology On Pain, Anxiety And Comfort Level
A study testing reflexology massage in people with Myocardial Infarction and Angina Pectoris, run by Hakkari Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study was performed as a randomized controlled a study with a pre test-post test design, aimed to determine affect of reflexology masagge to the pain, anxiety and comfort level on the patients that are percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myocardial Infarction, Angina Pectoris
- What is being tested?
- reflexology massage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 30 Sep 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old,
- Literate, Diagnosed with PCI-related pain,
- Pain score of 4 out of 10 according to Visual Comparison Scale (VAS) after PCI.
Who cannot join
- Presence of a pacemaker,
- Having a diagnosis of diabetic foot,
- Presence of vision, hearing, cognitive ability impairment or psychosis,
- Being pregnant,
- Presence of disc herniation,
- Any contagious skin disease (shingles, fungus, etc.), open lesion/wound on the lower extremities, scar tissue, fracture, dislocation, amputation, edema, hematoma, thrombophlebitis, inflammatory and degenerative joint disease,
- Having applied reflexology massage in the last month
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Regional Training and Research Hospital
Van, 65100
About this study
Official title: The Effect Of Reflexology Massage On Pain, Anxiety And Comfort Level In Patients Undergoing Percutaneous Coronary Intervention
This study was performed as a randomized controlled a study with a pre test-post test design, aimed to determine affect of reflexology masagge to the pain, anxiety and comfort level on the patients that are percutaneous coronary intervention.
Read the detailed description
A total of 74 patients, 37 in the experimental group and 37 in the placebo group, who met the criteria for inclusion in the study, constituted the sample of the study. Research data were collected with "Structured Patient Information Form", "Vital Signs Form", "State Anxiety Scale", "Visual Comparison Scale", "McGill Pain Scale Short Form" and "General Comfort Scale Short Form". Appropriate statistical methods were used in the analysis of the data.
Reflexology massage is a well tolerated, inexpensive, applicable and safe non-pharmacological method. The fact that nurses are educated and experienced about reflexology massage is of great importance for integrating reflexology massage into clinical settings.
If the results of this study are significant, it will be concluded that reflexology massage is effective in the management of pain and anxiety and increasing the comfort level in patients undergoing PCI. It will be recommended that reflexology massage be used in clinics to reduce pain, anxiety and increase comfort level in individuals undergoing PCI, and to include it in patient education. No study has been found in the national literature evaluating the effectiveness of reflexology massage in the management of PCI-related pain, anxiety and comfort. It is thought that this study will fill an important gap in the literature. The aim of this study, carried out in this context, is to reveal the effect of reflexology massage on pain, anxiety and comfort level in patients undergoing PCI.
- Conditions
- Myocardial Infarction, Angina Pectoris
- Being tested
- reflexology massage, Placebo massage
- Medical subject headings
- Myocardial Infarction, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reflexology massageOther
5 minutes of classic message on the left foot, 15 minutes of reflexology message, and 5 minutes of classic message on the right foot, 15 minutes of reflexology message, a total of 40 minutes of massage. 30 minutes after the massage, evaluation was recorded with the Vital Signs Registration Form, McGill Pain Scale Short Form, State Anxiety Inventory, General Comfort Scale Short Form, and Fatigue and Quality Sleep Visual Comparison Scale. Thus, reflexology massage is performed once a day for each patient for 2 consecutive days, for a total of 2 sessions.
Placebo massageOther
Placebo reflexology massage was applied to each foot for 20 minutes, for a total of 40 minutes.30 minutes after the massage, evaluation was recorded with the Vital Signs Registration Form, McGill Pain Scale Short Form, State Anxiety Inventory, General Comfort Scale Short Form, and Fatigue and Quality Sleep Visual Comparison Scale. Thus, Placebo massage is performed once a day for each patient for 2 consecutive days, for a total of 2 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Active comparator | it was planned to apply reflexology massage once a day for each patient for 2 consecutive days, in total 2 sessions. Receives: Other: reflexology massage |
| placebo group | Placebo comparator | placebo massage was applied once a day for each patient for 2 consecutive days, for a total of 2 sessions. Receives: Other: Placebo massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
The McGill Pain Scale Short Form-2
The McGill Pain Scale Short Form, developed by Melzack in 1987, provides information about the sensory characteristics, severity and effect of pain. The validity and reliability study in Turkey was developed by Yakut et al. in 2007. McGill Pain Scale Short Form-2 (MAS-SF-2) was developed in 2010 by revising the McGill Pain Scale Short Form by Bicici and Günes.
Measured: 2 days
Secondary outcomes (1)
State-Trait Anxiety Inventory
It was developed by Spielberger et al. in 1970 and validated and reliable in Turkish society by Öner and Le Compte (1977). The State-Trait Anxiety Inventory consists of two different parts and includes a total of 40 items, 20 of which are each.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start1 Jul 2021
- Primary completion27 Feb 2022
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies 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
- consists of experimental and placebo groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hakkari Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamber Sumer, Hakkari Universitesi
- Investigators
- Kamber SÜMER, Principal investigator, PhD student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007716
- Sponsor's protocol ID
- HU-SM-KM-01
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2023
- Last updated
- 23 Aug 2023
- 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 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Reflexology Massage On Pain, Anxiety And Comfort Level In Patients Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT06007716
- Acronym / sponsor ID
- HU-SM-KM-01
- Conditions
- Myocardial Infarction, Angina Pectoris
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Hakkari UniversitesiUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 27 Feb 2022 (actual)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 23 Aug 2023 (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.
This study was performed as a randomized controlled a study with a pre test-post test design, aimed to determine affect of reflexology masagge to the pain, anxiety and comfort level on the patients that are percutaneous coronary intervention.
Detailed description
A total of 74 patients, 37 in the experimental group and 37 in the placebo group, who met the criteria for inclusion in the study, constituted the sample of the study. Research data were collected with "Structured Patient Information Form", "Vital Signs Form", "State Anxiety Scale", "Visual Comparison Scale", "McGill Pain Scale Short Form" and "General Comfort Scale Short Form". Appropriate statistical methods were used in the analysis of the data.
Reflexology massage is a well tolerated, inexpensive, applicable and safe non-pharmacological method. The fact that nurses are educated and experienced about reflexology massage is of great importance for integrating reflexology massage into clinical settings.
If the results of this study are significant, it will be concluded that reflexology massage is effective in the management of pain and anxiety and increasing the comfort level in patients undergoing PCI. It will be recommended that reflexology massage be used in clinics to reduce pain, anxiety and increase comfort level in individuals undergoing PCI, and to include it in patient education. No study has been found in the national literature evaluating the effectiveness of reflexology massage in the management of PCI-related pain, anxiety and comfort. It is thought that this study will fill an important gap in the literature. The aim of this study, carried out in this context, is to reveal the effect of reflexology massage on pain, anxiety and comfort level in patients undergoing PCI.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- consists of experimental and placebo groups.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Active comparator | Other: reflexology massageit was planned to apply reflexology massage once a day for each patient for 2 consecutive days, in total 2 sessions. |
| placebo group | Placebo comparator | Other: Placebo massageplacebo massage was applied once a day for each patient for 2 consecutive days, for a total of 2 sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years old,
- Literate, Diagnosed with PCI-related pain,
- Pain score of 4 out of 10 according to Visual Comparison Scale (VAS) after PCI.
Key exclusion criteria (7 listed)
- Presence of a pacemaker,
- Having a diagnosis of diabetic foot,
- Presence of vision, hearing, cognitive ability impairment or psychosis,
- Being pregnant,
- Presence of disc herniation,
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 |
|---|---|---|
| reflexology massage5 minutes of classic message on the left foot, 15 minutes of reflexology message, and 5 minutes of classic message on the right foot, 15 minutes of reflexology message, a total of 40 minutes of massage. 30 minutes after the massage, evaluation was recorded with the Vital Signs Registration Form, McGill Pain Scale Short Form, State Anxiety Inventory, General Comfort Scale Short Form, and Fatigue and Quality Sleep Visual Comparison Scale. Thus, reflexology massage is performed once a day for each patient for 2 consecutive days, for a total of 2 sessions. | Other | Experimental group |
| Placebo massagePlacebo reflexology massage was applied to each foot for 20 minutes, for a total of 40 minutes.30 minutes after the massage, evaluation was recorded with the Vital Signs Registration Form, McGill Pain Scale Short Form, State Anxiety Inventory, General Comfort Scale Short Form, and Fatigue and Quality Sleep Visual Comparison Scale. Thus, Placebo massage is performed once a day for each patient for 2 consecutive days, for a total of 2 sessions. | Other | placebo group |
Primary outcome
The McGill Pain Scale Short Form-2
Time frame: 2 days
The McGill Pain Scale Short Form, developed by Melzack in 1987, provides information about the sensory characteristics, severity and effect of pain. The validity and reliability study in Turkey was developed by Yakut et al. in 2007. McGill Pain Scale Short Form-2 (MAS-SF-2) was developed in 2010 by revising the McGill Pain Scale Short Form by Bicici and Günes.
1 secondary outcome
State-Trait Anxiety Inventory
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Myocardial Infarction
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
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.
Kamber SÜMER principal investigator
PhD student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reflexology massage in people with Myocardial Infarction and Angina Pectoris, run by Hakkari Universitesi 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 23 Aug 2023. 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?
Results are not available in the source record.
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?
The McGill Pain Scale Short Form-2 (time frame: 2 days). 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 23 Aug 2023.