The Effect of Hand Reflexology on Anxiety and Vital Signs With Angiography

NCT04956055 | Unknown DMC

• 1 other identifier: 16.03.2020-35
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study was planned to determine the effect of hand reflexology on anxiety and vital signs in patients undergoing coronary angiography. In the G-power analysis conducted to determine the sample of the study, experiment and control were calculated as 60 in total, with the sample number of both groups being 30. Since the study is a single-blind randomized clinical trial, in order to determine the randomization , a box with the names of the patients determined according to the participation criteria will be determined by the selection of the healthcare personnel responsible for the service, and the experimental and control groups. "Demographic Data Form" , "Distress Thermometer". "State Anxiety Inventory" , "Vital Signs Form" and Visual Analog Scale will be used to collect research data.

Conditions

Coronary Artery Disease; Coronary Disease

Keywords

anxiety; life findings; coronary angiography; distress; reflexology; angiography

Outcome Measures

Primary Outcomes (1)

• Demographic form

  This form created by the researcher includes the patient's age, gender, marital status, smoking and alcohol use status, job, education level, country of origin, chronic illness, reason for angiography.

  15 July 2021-15 October 2021three months (face to face interview)

Secondary Outcomes (1)

• Distress thermometer:

  15 July 2021-15 October 2021 three months (face to face interview) patient mark number related to distress

Other Outcomes (3)

• Vital signs

  15 July 2021-15 October 2021 three months (fever-centigrade, respiration per minute, blood pressure mmHg)

• State anxiety inventory

  15 July 2021-15 October 2021 5 minute (face to face interview) patient mark statement and give score

• Visual Analog Scale

  15 July 2021-15 October 2021 three months (face to face interview) patient mark number related to pain

Study Arms (2)

Experiment group

EXPERIMENTAL

Experimental group to be applied hand reflexology

Other: Reflexology

Control group

NO INTERVENTION

experimental group for which hand reflexology will not be applied

Interventions

Reflexology OTHER

The patient will be kept in a lying position. First, the patient will be given four minutes of hand reflexology on each hand with warming and stimulation techniques.Reflexology will be applied to the left hand with the thumb of the right hand, the thumb of the left hand and the special points in the right hand. It will be applied to the fingers, palm, back of the hand, and finally the wrists, respectively, starting with the fingertips and using special reflexology techniques (a total of six minutes for each hand separately). By sending a moderate stimulus, a total of 20 minutes of reflexology session will continue.Since the patient reveals and uses his own internal energy at the end of the session, nobody should talk to the patient until five minutes after the procedure. Survey questions and vital signs would be examined five minutes after the session and the research with the participant would end.

Experiment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be applied coronary angiography for the first time waiting for coronary angiography on the same day,
• Patients over the age of 18,
• Physically and mentally patients have the ability to fill forms,
• Patients who will undergo femoral angiography, that patients agree to participate in research

You may not qualify if:

• Patients who do not accept the study,
• Who are physically and mentally unable to fill the forms,
• Who have sudden changes in vital signs,
• Who do not voluntarily continue

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Gebze Fatih Hospital

Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Disease; Anxiety Disorders

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Hatice Karabuga Yakar

  Marmara University

  STUDY DIRECTOR

Central Study Contacts

Hatice Karabuga Yakar, PhD

CONTACT

905356895745; hatice.karabuga@gmail.com

Habibe Engin, RN

CONTACT

905382032517; hemsire3505@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single blind randomized controlled trial

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: July 9, 2021
• Study Start: July 15, 2021
• Primary Completion: September 15, 2021
• Study Completion: January 15, 2022
• Last Updated: July 9, 2021

Record last verified: 2021-01

Locations

TU (1)