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PainNCT05082506

Effect of Acupressure on Pain, Anxiety and Vital Signs in Patients With Coronary Angiography

A study testing Acupressure in people with Pain and Anxiety, run by Eastern Mediterranean University at 1 site in Cyprus.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The study was planned to determine the effect of acupressure on pain, anxiety and vital signs of patients with coronary angiography. Acupressure application was carried out by the responsible researcher, who is certified on this subject, by TRNC Dr. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Pain, Anxiety, Vital Signs
What is being tested?
Acupressure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
105 participants
Where
1 siteCyprus
Study dates
15 Dec 2021to 31 Dec 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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • First time coronary angiography performed
  • Coronary angiography performed from the femoral region,
  • over the age of 18,
  • Willing to participate in the research,
  • Able to understand and speak Turkish,
  • Open to communication,
Show all 16Show fewer
  • Planned (non-urgent) coronary angiography
  • No complications after angiography
  • Stent etc. during angiography. no other attempt has been made
  • No deformity or lesion in the areas where acupressure will be applied
  • Not taking sedatives or pain relievers 5 hours before the angiography procedure,
  • No acupressure experience
  • Not diagnosed with anxiety disorder and not receiving medical treatment
  • Not diagnosed with depression and not receiving medical treatment
  • No chronic pain
  • Patients without mental illness.

Who cannot join

  • - Previous coronary angiography
  • Coronary angiography from the femoral region is not performed,
  • under the age of 18,
  • pregnant,
  • Those who do not agree to participate in the research,
  • Can't understand or speak Turkish,
Show all 17Show fewer
  • Unable to communicate
  • Unplanned (urgent) Coronary angiography Patients
  • Any complications after angiography
  • Stent etc. during angiography. another attempt has been made
  • Any deformity or lesion in the areas where acupressure will be applied,
  • Those who took sedatives or painkillers 5 hours before the angiography procedure,
  • Experience with acupressure
  • Anxiety disorder and receiving treatment,
  • Diagnosed with depression and receiving treatment,
  • Having chronic pain,
  • Patients with mental disorders.

Trial locations and contacts

1 site in 1 country.

Cyprus1 site
  • Selda Bal

    Famagusta, 99450

    selda bal, 1, 05338717636, selda.bal@emu.edu.tr

    meral gün, 2, 05337301788, meralgun@mersin.edu.tr

Other trials in Cyprus

About this study

Official title: Effect of Acupressure on Pain, Anxiety and Vital Signs in Patients With Coronary Angiography: A Randomized Controlled Study

The study was planned to determine the effect of acupressure on pain, anxiety and vital signs of patients with coronary angiography. Acupressure application was carried out by the responsible researcher, who is certified on this subject, by TRNC Dr. In the Cardiology Service of Burhan Nalbantoğlu Hospital, patients who have undergone angiography will be applied and measurements will be made before mobilization after their informed consent is obtained.

Read the detailed description

In this study, it is aimed to raise awareness for the use of painless, painless, economical, side-effect-free and easy-to-apply acupressure in nursing care in order to increase patient comfort by relieving pain and anxiety of patients during mandatory bed rest after coronary angiography. In addition, our study is important in terms of providing new information with a high level of evidence and providing a source for other studies on this subject.

Objective: The study was planned to determine the effect of acupressure on pain, anxiety and vital signs of patients with coronary angiography.

Hypothesis 1 H0: There is no difference in Visual Analog Scale mean scores between the acupressure group, the sham (pseudo-acupressure) group, and the control group.

H1: There is a difference in Visual Analog Scale mean scores between the acupressure group, the sham (pseudo-acupressure) group, and the control group.

Hypothesis 2 H0: There is no difference between the Spielberger State Anxiety Inventory mean scores between the acupressure group, the sham (pseudo-acupressure) group, and the control group.

H1: There is a difference between the Spielberger State Anxiety Inventory mean scores between the acupressure group, the sham (pseudo-acupressure) group, and the control group.

Hypothesis 3 H0: There is no difference in Systolic Blood Pressure between the acupressure group, the sham (false acupressure) group and the control group.

H1: There is a difference in Systolic Blood Pressure between the acupressure group, the sham (false acupressure) group and the control group.

Hypothesis 4 H0: There is no difference in Diastolic Blood Pressure between the acupressure group, the sham (false acupressure) group and the control group.

H1: There is a difference in Diastolic Blood Pressure between the acupressure group, the sham (false acupressure) group and the control group.

Hypothesis 5 H0: There is no difference in Heart Rate between the acupressure group, the sham (false acupressure) group and the control group.

H1: There is a difference between the acupressure group, the sham (false acupressure) group and the control group in terms of Heart Rate.

Hypothesis 6 H0: There is no difference in Respiration Rate between the acupressure group, the sham (false acupressure) group and the control group.

H1: There is a difference between the acupressure group, the sham (false acupressure) group and the control group in terms of Respiration Rate.

Hypothesis 7 H0: There is no difference in Cortisol Level between the acupressure group, the sham (false acupressure) group and the control group.

H1: There is a difference between the acupressure group, the sham (false acupressure) group and the control group in terms of Cortisol Level.

"Personal Information Form, "Spielberger State Anxiety Scale", "Visual Analogue Scale" and "Vital Signs Follow-up Form" will be administered to all patients (acupressure, sham acupressure and control groups) included in the study (1. "Spielberger State Anxiety Inventory", "After the measurement, half an hour after applying acupressure to the points determined for both groups (2nd measurement), two hours later (3rd measurement) and just before mobilization (4th measurement)," "Visual Analogue Scale" and "Vital Signs Follow-up Form" will be applied again.

It was created by the researcher to track the cortisol level. It is designed to include a total of 2 measurements (pre/post acupressure).

Being tested
Acupressure
Keywords
pain, anxiety, vital signs, coronary angiography
Medical subject headings
Pain, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcupressureBehavioural

    Afterwards, sequential (breathing rhythm) compressions will be applied to the determined acupressure points by the researcher without lifting the finger, taking into account the pain threshold of the individual who is applied with the thumb, with 10 seconds of pressure for two seconds of relief.

Study groups in NCT05082506
Study groupRoleWhat they receive
Acupressure GroupExperimentalApplicable to the acupressure group; Heart meridian 7th point (HT7), large intestine meridian 4th point (LI4) and pericardium 6th point (PC6), a total of three points will be applied. Afterwards, sequential (breathing rhythm) compressions will be applied to the determined acupressure points by the researcher without lifting the finger, taking into account the pain threshold of the individual who is applied with the thumb, with 10 seconds of pressure for two seconds of relief. Since the symmetry of the selected three different points on the other extremity will also be applied, a total of 12 minutes of compression will be applied to each point, provided that it is two minutes. Depending on the preparation and compression time on each point, the session duration of each patient will be approximately 16 minutes.
Receives: Behavioral: Acupressure
Sham GroupPlacebo comparatorn the acupressure application to the Sham group, pressure will be exerted on the bone region where the meridians do not pass, parallel to the HT7, LI4, PC6 and points (approximately 1-1.5 cm away) (Figure 4). Before the application, the acupressure points will be heated for about 20 seconds and the tissue sensitivity will be reduced by rubbing and they will be made ready for the acupressure application. Afterwards, the acupressure points determined will be pressed with the thumb by the researcher with a lower intensity than the normal application pressure for two minutes. Similar to the acupressure group, the sham group will be applied to symmetrical points. In this direction, a session will last 16 minutes for each patient, as in the acupressure group, together with the duration of the pre-procedure preparation and applications.
Receives: Behavioral: Acupressure
Control GroupNo interventionPatients in the control group will not receive any intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Spielberger State Anxiety Scale

    The scale consists of 20 statements. The total score can range from 20 to 80. A high score indicates a high level of anxiety, and a low score indicates a low level of anxiety.

    Measured: 6 month

Secondary outcomes (1)
  1. Visual Pain Scale

    It is a scale that is evaluated by individuals by making markings on a horizontal or vertical line of 10 cm or 100 mm, one end of which indicates that the patient is very good and the other end is very bad.

    Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2021
  2. Study start15 Dec 2021 (estimated)
  3. Primary completion30 Jun 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

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
Since the patients who will be included in the study are not known in advance, the patients will be randomized by the statistician using GraphPad software 3 and the block randomization technique, in order to assign the same number of participants to each group before the study, and will be divided into groups A, B, and C.
Masking
Single blind
Who is masked
Participant
Enrolment
105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05082506
Sponsor's protocol ID
41/21
Status last verified
Oct 2021
First submitted
8 Sep 2021
Last updated
19 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Virani SS, Alonso A, Aparicio HJ, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Cheng S, Delling FN, Elkind MSV, Evenson KR, Ferguson JF, Gupta DK, Khan SS, Kissela BM, Knutson KL, Lee CD, Lewis TT, Liu J, Loop MS, Lutsey PL, Ma J, Mackey J, Martin SS, Matchar DB, Mussolino ME, Navaneethan SD, Perak AM, Roth GA, Samad Z, Satou GM, Schroeder EB, Shah SH, Shay CM, Stokes A, VanWagner LB, Wang NY, Tsao CW; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2021 Update: A Report From the American Heart Association. Circulation. 2021 Feb 23;143(8):e254-e743. doi: 10.1161/CIR.0000000000000950. Epub 2021 Jan 27.

    PubMed 33501848
  • Sharif F, Najafi Kalyani M, Ahmadi F, Iman MT. In the shadow of perceived threat: The live experience of Iranian patients candidate for undergoing coronary angiography. J Vasc Nurs. 2018 Sep;36(3):140-144. doi: 10.1016/j.jvn.2018.04.004. Epub 2018 Jun 7.

    PubMed 30139451
  • Caldwell PH, Arthur HM, Natarajan M, Anand SS. Fears and beliefs of patients regarding cardiac catheterization. Soc Sci Med. 2007 Sep;65(5):1038-48. doi: 10.1016/j.socscimed.2007.04.010. Epub 2007 May 15.

    PubMed 17507132
  • Shoulders-Odom B. Management of patients after percutaneous coronary interventions. Crit Care Nurse. 2008 Oct;28(5):26-41; quiz 42. No abstract available.

    PubMed 18827085
  • Fereidouni Z, Kameli Morandini M, Najafi Kalyani M. The efficacy of interventions for back pain in patients after transfemoral coronary angiography: A rapid systematic review. J Vasc Nurs. 2019 Mar;37(1):52-57. doi: 10.1016/j.jvn.2018.11.002. Epub 2018 Dec 17.

    PubMed 30954199
  • Tolentino JC, Schmidt JJ, Schmidt GJ, Mesquita CT, Schmidt SL. Mental Stress-Induced Myocardial Ischemia Related to Generalized Anxiety Disorder in a Patient With Acute Coronary Syndrome and Normal Coronary Arteries. Clin Nucl Med. 2016 Nov;41(11):e487-e490. doi: 10.1097/RLU.0000000000001348.

    PubMed 27607164
  • Au DW, Tsang HW, Ling PP, Leung CH, Ip PK, Cheung WM. Effects of acupressure on anxiety: a systematic review and meta-analysis. Acupunct Med. 2015 Oct;33(5):353-9. doi: 10.1136/acupmed-2014-010720. Epub 2015 May 22.

    PubMed 26002571
  • Khoram B, Yoosefinejad AK, Rivaz M, Najafi SS. Investigating the Effect of Acupressure on the Patients' Anxiety Before Open-Heart Surgery: A Randomized Clinical Trial. J Acupunct Meridian Stud. 2020 Dec;13(6):169-173. doi: 10.1016/j.jams.2020.11.001. Epub 2020 Nov 24.

    PubMed 33242637
  • Sharifi Rizi M, Shamsalinia A, Ghaffari F, Keyhanian S, Naderi Nabi B. The effect of acupressure on pain, anxiety, and the physiological indexes of patients with cancer undergoing bone marrow biopsy. Complement Ther Clin Pract. 2017 Nov;29:136-141. doi: 10.1016/j.ctcp.2017.09.002. Epub 2017 Sep 5.

    PubMed 29122251
  • Bal SK, Gun M. The effects of acupressure on pain, anxiety and vital signs in patients undergoing coronary angiography: A randomized and sham-controlled trial. Explore (NY). 2024 Jan-Feb;20(1):101-109. doi: 10.1016/j.explore.2023.07.001. Epub 2023 Jul 4.

    PubMed 37429762

Questions about this trial

What is this clinical trial studying?

A study testing Acupressure in people with Pain and Anxiety, run by Eastern Mediterranean University at 1 site in Cyprus.

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 16 inclusion and 17 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 19 Oct 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 Cyprus. 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?

Contact SELDA BAL, 1 (+905338717636, selda.bal@emu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Spielberger State Anxiety Scale (time frame: 6 month). 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 NCT05082506, which also lists 10 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 19 Oct 2021; AzTrials last refreshed its copy on 8 Nov 2026.

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