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OpenTrials
Completed

NCT Number: NCT06534294

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

Completed

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Key information

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al Ryada University for Science and Technology

Sadat, Menofia, 32897, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

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

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.

Standard care

Other

standard medical care no other treatment

Primary outcomes

  1. Cortisol Levels

    Time frame: At subject enrollment "single session"

    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

  2. Distress Thermometer

    Time frame: At subject enrollment "single session"

    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.

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 2, 2024
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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