NCT06077175

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 11, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 30, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

March 3, 2025

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

October 5, 2023

Last Update Submit

February 27, 2025

Conditions

Keywords

acute coronary syndromeanxietycomforthan massage

Outcome Measures

Primary Outcomes (2)

  • Beck Anxiety Scale

    It is a self-rating scale used to determine the frequency of anxiety symptoms experienced by individuals.

    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.

    It will be applied on the 4th day at the end of the application.

Secondary Outcomes (2)

  • General Comfort Scale

    It will be done before the massage application, 24 hours after arrival in the intensive care unit.

  • General Comfort Scale

    It will be applied on the 4th day at the end of the application.

Study Arms (2)

intervention group

EXPERIMENTAL
Other: hand massage group

Control group

NO INTERVENTION

Interventions

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.

intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients experiencing Acute Coronary Syndrome for the first time,
  • Anxiety score of 16 and above (moderate and severe anxiety)
  • years and above,
  • No psychiatric disease,
  • Patients who do not have communication problems and are competent to answer all questions,

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University Hospital

Kayseri, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 26646596BACKGROUND
  • Alimohammad 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.

    PMID: 29705444BACKGROUND
  • Cavdar 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.

    PMID: 31551136BACKGROUND
  • Kunikata 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.

    PMID: 22450009BACKGROUND

MeSH Terms

Conditions

Acute Coronary SyndromeAnxiety Disorders

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching staff

Study Record Dates

First Submitted

October 5, 2023

First Posted

October 11, 2023

Study Start

November 30, 2023

Primary Completion

March 1, 2024

Study Completion

June 1, 2024

Last Updated

March 3, 2025

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations