Acute Coronary SyndromeNCT06077175
HAND MASSAGE AFTER ACUTE CORONARY SYNDROME
A study testing hand massage group in people with Acute Coronary Syndrome and Anxiety, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Patients suffering from Acute coronary syndrome may be hospitalized again in a shorter time than expected, and after being discharged, they may live within the limitations imposed by the disease until the end of their lives. This situation causes anxiety in individuals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndrome, Anxiety
- What is being tested?
- hand massage group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2023to 1 Jun 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients experiencing Acute Coronary Syndrome for the first time,
- Anxiety score of 16 and above (moderate and severe anxiety)
- 18 years and above,
- No psychiatric disease,
- Patients who do not have communication problems and are competent to answer all questions,
Who cannot join
- Patients with uncontrolled Diabetes mellitus
- Patients who cannot communicate and have confusion,
- Those who have any limb, vascular problem or wound that prevents hand massage,
- Thrombophlebitis, occlusive arterial disease, fever etc. Those for whom massage therapy is inconvenient due to illness,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECT of HAND MASSAGE on PATIENTS AFTER ACUTE CORONARY SYNDROME on the COMFORT and ANXIETY LEVEL
Patients suffering from Acute coronary syndrome may be hospitalized again in a shorter time than expected, and after being discharged, they may live within the limitations imposed by the disease until the end of their lives. This situation causes anxiety in individuals. Today, various methods are used to reduce high levels of anxiety. Massage is the planned and purposeful application of touch and is the most common, most important and oldest complementary treatment used in traditional practices. It is also thought that the comfort levels of individuals experiencing ACS will increase by reducing their anxiety. This study was planned to determine the effect of hand massage applied to patients with ACS on comfort, anxiety level and vital signs.
- Conditions
- Acute Coronary Syndrome, Anxiety
- Being tested
- hand massage group
- Keywords
- acute coronary syndrome, anxiety, comfort, han massage
- Medical subject headings
- Acute Coronary Syndrome, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hand massage groupOther
Each individual will receive a 10-minute hand massage, 5 minutes for each hand. Since the speed and number of repetitions of the massage movements should be at normal frequency, the massage will be performed at a speed that does not disturb the individual, is not stimulating and has a calming effect, and will not tire the practitioner. In the massage, effleurage (stroking) and friction (circular rubbing) movements will be used, which have a circulation-supporting and tissue-relaxing effect. Evaluations will be made within 30 minutes after the hand massage.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Not described Receives: Other: hand massage group |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Anxiety Scale
It is a self-rating scale used to determine the frequency of anxiety symptoms experienced by individuals.
Measured: It will be done before the massage application, 24 hours after arrival in the intensive care unit.
Beck Anxiety Scale
It is a self-rating scale used to determine the frequency of anxiety symptoms experienced by individuals.
Measured: It will be applied on the 4th day at the end of the application.
Secondary outcomes (2)
General Comfort Scale
It is used to determine the comfort level of patients.
Measured: It will be done before the massage application, 24 hours after arrival in the intensive care unit.
General Comfort Scale
It is used to determine the comfort level of patients.
Measured: It will be applied on the 4th day at the end of the application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start30 Nov 2023
- Primary completion1 Mar 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Ceyhan, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077175
- Sponsor's protocol ID
- AKSHAND
- Status last verified
- Oct 2023
- First submitted
- 5 Oct 2023
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mei L, Miao X, Chen H, Huang X, Zheng G. Effectiveness of Chinese Hand Massage on Anxiety Among Patients Awaiting Coronary Angiography: A Randomized Controlled Trial. J Cardiovasc Nurs. 2017 Mar/Apr;32(2):196-203. doi: 10.1097/JCN.0000000000000309.
PubMed 26646596Alimohammad HS, Ghasemi Z, Shahriar S, Morteza S, Arsalan K. Effect of hand and foot surface stroke massage on anxiety and vital signs in patients with acute coronary syndrome: A randomized clinical trial. Complement Ther Clin Pract. 2018 May;31:126-131. doi: 10.1016/j.ctcp.2018.01.012. Epub 2018 Feb 13.
PubMed 29705444Cavdar AU, Yilmaz E, Baydur H. The Effect of Hand Massage Before Cataract Surgery on Patient Anxiety and Comfort: A Randomized Controlled Study. J Perianesth Nurs. 2020 Feb;35(1):54-59. doi: 10.1016/j.jopan.2019.06.012. Epub 2019 Sep 21.
PubMed 31551136Kunikata H, Watanabe K, Miyoshi M, Tanioka T. The effects measurement of hand massage by the autonomic activity and psychological indicators. J Med Invest. 2012;59(1-2):206-12. doi: 10.2152/jmi.59.206.
PubMed 22450009
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT of HAND MASSAGE on PATIENTS AFTER ACUTE CORONARY SYNDROME on the COMFORT and ANXIETY LEVEL
- ClinicalTrials.gov ID
- NCT06077175
- Acronym / sponsor ID
- AKSHAND
- Conditions
- Acute Coronary Syndrome, Anxiety
- Keywords
- acute coronary syndrome, anxiety, comfort, han massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 11 Oct 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.
Patients suffering from Acute coronary syndrome may be hospitalized again in a shorter time than expected, and after being discharged, they may live within the limitations imposed by the disease until the end of their lives. This situation causes anxiety in individuals. Today, various methods are used to reduce high levels of anxiety. Massage is the planned and purposeful application of touch and is the most common, most important and oldest complementary treatment used in traditional practices. It is also thought that the comfort levels of individuals experiencing ACS will increase by reducing their anxiety. This study was planned to determine the effect of hand massage applied to patients with ACS on comfort, anxiety level and vital signs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: hand massage group |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients experiencing Acute Coronary Syndrome for the first time,
- Anxiety score of 16 and above (moderate and severe anxiety)
- 18 years and above,
- No psychiatric disease,
- Patients who do not have communication problems and are competent to answer all questions,
Key exclusion criteria (4 listed)
- Patients with uncontrolled Diabetes mellitus
- Patients who cannot communicate and have confusion,
- Those who have any limb, vascular problem or wound that prevents hand massage,
- Thrombophlebitis, occlusive arterial disease, fever etc. Those for whom massage therapy is inconvenient due to illness,
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 |
|---|---|---|
| hand massage groupEach individual will receive a 10-minute hand massage, 5 minutes for each hand. Since the speed and number of repetitions of the massage movements should be at normal frequency, the massage will be performed at a speed that does not disturb the individual, is not stimulating and has a calming effect, and will not tire the practitioner. In the massage, effleurage (stroking) and friction (circular rubbing) movements will be used, which have a circulation-supporting and tissue-relaxing effect. Evaluations will be made within 30 minutes after the hand massage. | Other | intervention group |
Primary outcome
Beck Anxiety Scale
Time frame: It will be done before the massage application, 24 hours after arrival in the intensive care unit.
It is a self-rating scale used to determine the frequency of anxiety symptoms experienced by individuals.
Beck Anxiety Scale
Time frame: It will be applied on the 4th day at the end of the application.
It is a self-rating scale used to determine the frequency of anxiety symptoms experienced by individuals.
2 secondary outcomes
General Comfort Scale
Time frame: It will be done before the massage application, 24 hours after arrival in the intensive care unit.
General Comfort Scale
Time frame: It will be applied on the 4th day at the end of the application.
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 3 Mar 2025.
- Background: PubMed 26646596Mei L, Miao X, Chen H, Huang X, Zheng G. Effectiveness of Chinese Hand Massage on Anxiety Among Patients Awaiting Coronary Angiography: A Randomized Controlled Trial. J Cardiovasc Nurs. 2017 Mar/Apr;32(2):196-203. doi: 10.1097/JCN.0000000000000309.
- Background: PubMed 29705444Alimohammad HS, Ghasemi Z, Shahriar S, Morteza S, Arsalan K. Effect of hand and foot surface stroke massage on anxiety and vital signs in patients with acute coronary syndrome: A randomized clinical trial. Complement Ther Clin Pract. 2018 May;31:126-131. doi: 10.1016/j.ctcp.2018.01.012. Epub 2018 Feb 13.
- Background: PubMed 31551136Cavdar AU, Yilmaz E, Baydur H. The Effect of Hand Massage Before Cataract Surgery on Patient Anxiety and Comfort: A Randomized Controlled Study. J Perianesth Nurs. 2020 Feb;35(1):54-59. doi: 10.1016/j.jopan.2019.06.012. Epub 2019 Sep 21.
- Background: PubMed 22450009Kunikata H, Watanabe K, Miyoshi M, Tanioka T. The effects measurement of hand massage by the autonomic activity and psychological indicators. J Med Invest. 2012;59(1-2):206-12. doi: 10.2152/jmi.59.206.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hand massage group in people with Acute Coronary Syndrome and Anxiety, run by TC Erciyes 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 5 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 3 Mar 2025. 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?
Beck Anxiety Scale (time frame: It will be done before the massage application, 24 hours after arrival in the intensive care unit.). 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 NCT06077175, which also lists 4 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 3 Mar 2025.