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

NCT06534294 | Completed

• 1 other identifier: IHC00070
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Percutaneous Transluminal Coronary Angioplasty

Outcome Measures

Primary Outcomes (2)

• 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"

Study Arms (4)

GROUP1

EXPERIMENTAL

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

GROUP2

EXPERIMENTAL

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

GROUP3

EXPERIMENTAL

procedure that will done in reflexology and deep breathing will applied

Other: reflexology; Other: breathing exercise

GROUP4

OTHER

In this group: will received only standard care

Other: standard care

Interventions

reflexology OTHER

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

GROUP1; GROUP3

breathing exercise OTHER

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.

GROUP2; GROUP3

standard care OTHER

standard medical care no other treatment

GROUP4

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• October 6 University: lead

Study Sites (1)

Al Ryada University for Science and Technology

Sadat, Menofia, 32897, Egypt

Location

MeSH Terms

Interventions

Musculoskeletal Manipulations; Breathing Exercises; Standard of Care

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Mind-Body Therapies; Exercise Movement Techniques; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: August 2, 2024
• Study Start: March 2, 2024
• Primary Completion: June 12, 2024
• Study Completion: July 12, 2024
• Last Updated: August 2, 2024

Record last verified: 2024-08

Locations

EG (1)