CClinicalTrials.gg
CompletedNCT06534294Updated Aug 2, 2024

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

An interventional study of reflexology and breathing exercise in Percutaneous Transluminal Coronary Angioplasty, sponsored by October 6 University. Completed at 1 site in Egypt. Open to participants aged 30 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-08-02.

Sponsored by October 6 University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Mar 2024, registered Jul 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
30 Years to 50 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Percutaneous Transluminal Coronary Angioplasty
03

In context

Lead sponsor

October 6 University is the lead sponsor of 135 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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,
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • 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

  • 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

  • Experimental
    GROUP3

    procedure that will done in reflexology and deep breathing will applied

    Other: reflexology · Other: breathing exercise

  • Other
    GROUP4

    In this group: will received only standard care

    Other: standard care

Interventions

  • Otherreflexology

    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

  • Otherbreathing 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.

  • Otherstandard care

    standard medical care no other treatment

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: At subject enrollment "single session"

  2. 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.

    Time frame: At subject enrollment "single session"

07

Study locations

1 site
  • Al Ryada University for Science and Technology
    Sadat, Menofia 32897, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06534294
Lead sponsor
October 6 University
Responsible party
Amira Mohamed Afify (Associate professor, October 6 University) — Principal investigator
First posted
Aug 2, 2024
Start date
Mar 2, 2024
Primary completion
Jun 12, 2024
Completion
Jul 12, 2024
Last update
Aug 2, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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