Effect of Non-pharmacological Anti-anxiety Exercises on Perceived Stress and Cortisol Level Before Elective Per Cutaneous Transluminal Coronary Angioplasty

Effect of non-pharmacological anti-anxiety exercises on Perceived Stress and cortisol level before elective percutaneous transluminal coronary angioplasty

Study Overview

• Status: Completed
• Conditions: Percutaneous Transluminal Coronary Angioplasty
• Intervention / Treatment: Other: reflexology; Other: breathing exercise; Other: standard care

Detailed Description

patients will be selected from national heart institute their age from 30 -50 years old. Patients will be assigned randomly into 4 groups 15 in each group, reflexology group, deep breathing group, combined group (reflexology and deep breathing) and control group. Before procedure two tools will used to collect data (demographic characteristics format the beginning once and Distress Thermometer scale before and 30 minutes after application in all groups ) in addition blood samples (5 mL) will take from all the patients on an empty stomach between 08:30 and 10:00 in the morning and 30 minutes after the application to determine the cortisol level in all groups

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Menofia
    • Sadat, Menofia, Egypt, 32897
      • Al Ryada University for Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Fully conscious patients, aged from 30 to 50 years.
• will do percutaneous transluminal coronary angioplasty for the first time without any problem of communication.
• accepting to give Blood samples available between 08:30 and 10:00 in the morning (to avoid differences in cortisol levels), and agreeing to participate in the study

Exclusion Criteria:

• having myocardial infarction symptoms,
• unconscious, having a surgery in the last 6 weeks,
• previously diagnosed with a psychiatric disorder or still having a psychiatric disease, using anxiety medication (psychotropic), corticosteroid, using estrogen or amphetamine derivative drugs,
• infection of the lower extremities, having varicose veins, having peripheral neuropathy and deep vein thrombosis or risk of development, high fever,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GROUP1; Reflexology procedure will applied to patients in calm, quiet patient room with adequate light and in the supine position. For the relaxation of patients 10 minutes of relaxation techniques and stimulation of the reflexology points before reflexology, Reflex therapy was done for each patient for 30 minutes, first for the right foot and then for the left foot (15 minutes each)	Other: reflexology; Reflex therapy was done for each patient for 30 minutes, first for the right foot and then for the left foot (15 minutes each) and breathing exercises in 3 stages
Experimental: GROUP2; patients carried out breathing exercises AS 3 stages(13), stage one Beginning stage for 5 minutes will ask the patients to Sit , Flatten the shoulders, open the legs, and place your arms at your sides naturally , Close eyes and focus on present feelings , stage two deep breathing stage for 10 minutes Exercises were deep breathing exercises; deep inspiration for 5 seconds and slow prolonged expiration for next 5 seconds, at a rate of 6 breaths/min, rest for one minute after each cycle , then apply the exercises again , end stage ; Close eyes and focus your present feelings, Then Relax the whole body for 5 minutes.	Other: breathing exercise; breathing exercise done as 3 stages,stage one for 5 minutes, stage two for 10 minutes end stage ; Close eyes and focus your present feelings, Then Relax the whole body for 5 minutes.
Experimental: GROUP3; procedure that will done in reflexology and deep breathing will applied	Other: reflexology; Reflex therapy was done for each patient for 30 minutes, first for the right foot and then for the left foot (15 minutes each) and breathing exercises in 3 stages; Other: breathing exercise; breathing exercise done as 3 stages,stage one for 5 minutes, stage two for 10 minutes end stage ; Close eyes and focus your present feelings, Then Relax the whole body for 5 minutes.
Other: GROUP4; In this group: will received only standard care	Other: standard care; standard medical care no other treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cortisol Levels	2 tubes of blood samples (5 mL) will take from the patients in all groups on an empty stomach between 08:30 and 10:00 in the morning and 30 minutes after the application to determine the cortisol level	At subject enrollment "single session"
Distress Thermometer	It is a visual analog scale consisting of only 1 question that patients can apply on their own. On the scale, there is a thermometer with numbers from 0 to 10. A score of 0 indicates that the individual has no distress, and a score of 10 indicates distress at the highest limit.	At subject enrollment "single session"

Collaborators and Investigators

• Sponsor: October 6 University

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2024
• Primary Completion (Actual): June 12, 2024
• Study Completion (Actual): July 12, 2024

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: August 1, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Actual): August 2, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IHC00070

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No