NCT06602128

Brief Summary

This randomised controlled trial will be conducted to evaluate the effect of breathing exercise on anxiety, pain and vital signs in patients undergoing coronary angiography before angiography. Hypotheses of the study; H11: The anxiety level of the patients who underwent breathing exercise is lower than the patients in the control group. H12: The pain level of the patients who underwent breathing exercise is lower than the control group H13: The vital signs of the patients who underwent breathing exercises are within normal limits compared to the control group. In the study, there will be an intervention group in which breathing exercise will be applied and a control group in which no intervention will be applied. Data will be collected with the pre-test data collection form half an hour before the angiography procedure in patients in the intervention and control groups. Patients in the intervention group will be given breathing exercises, while patients in the control group will not be subjected to any intervention. After the angioplasty procedure, data will be collected from the intervention and control groups with post-test data collection forms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

September 18, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2024

Completed
Last Updated

December 5, 2024

Status Verified

December 1, 2024

Enrollment Period

2 months

First QC Date

September 13, 2024

Last Update Submit

December 4, 2024

Conditions

Keywords

Vital SignsPainStress

Outcome Measures

Primary Outcomes (10)

  • Vital Signs Recording Form-Blood pressure values

    It is a form created by the researcher in which the blood pressure values of the patients are recorded.

    30 minutes before coronary angiography

  • Vital Signs Recording Form-Blood pressure values

    It is a form created by the researcher in which the blood pressure values of the patients are recorded.

    Within 15 minutes after the angiography procedure is completed and the patient is taken to bed

  • Vital Signs Recording Form- Saturation

    It is a form created by the researcher in which the saturation values of the patients are recorded.

    30 minutes before coronary angiography

  • Vital Signs Recording Form- Saturation

    It is a form created by the researcher in which the saturation values of the patients are recorded.

    Within 15 minutes after the angiography procedure is completed and the patient is taken to bed

  • Vital Signs Recording Form- Pulse values

    It is a form created by the researcher in which the pulse rates of the patients are recorded.

    30 minutes before coronary angiography

  • Vital Signs Recording Form- Pulse values

    It is a form created by the researcher in which the pulse rates of the patients are recorded.

    Within 15 minutes after the angiography procedure is completed and the patient is taken to bed

  • Visual Analogy Scale (VAS)

    It is a 10 cm ruler that reflects the minimum and maximum state of pain by using it horizontally or vertically. '0' indicates painlessness and "10" indicates the most severe pain. The patient marks the intensity of pain felt on this ruler.

    30 minutes before coronary angiography

  • Visual Analogy Scale (VAS)

    It is a 10 cm ruler that reflects the minimum and maximum state of pain by using it horizontally or vertically. '0' indicates painlessness and "10" indicates the most severe pain. The patient marks the intensity of pain felt on this ruler.

    Within 15 minutes after the angiography procedure is completed and the patient is taken to bed

  • State-Trait Anxiety Inventory (STAI-I)

    The scale developed by Spielberg et al. (1964) was adapted into Turkish by Öner and Le Compte (1974-1977). The reliability of the scale is determined between 0.83 and 0.92 and it requires the person to understand his/her situation at certain times and conditions and to mark one of the preferences '1 (Not at all), 2 (A little), 3 (Very), 4 (Completely)' according to its severity. The total score obtained from the scale varies between 20-80 and 20-39 indicates mild anxiety level, 40-59 indicates moderate anxiety level, 60-79 indicates high anxiety level and 80 points indicates panic anxiety level.

    30 minutes before coronary angiography

  • State-Trait Anxiety Inventory (STAI-I)

    The scale developed by Spielberg et al. (1964) was adapted into Turkish by Öner and Le Compte (1974-1977). The reliability of the scale is determined between 0.83 and 0.92 and it requires the person to understand his/her situation at certain times and conditions and to mark one of the preferences '1 (Not at all), 2 (A little), 3 (Very), 4 (Completely)' according to its severity. The total score obtained from the scale varies between 20-80 and 20-39 indicates mild anxiety level, 40-59 indicates moderate anxiety level, 60-79 indicates high anxiety level and 80 points indicates panic anxiety level.

    Within 15 minutes after the angiography procedure is completed and the patient is taken to bed

Study Arms (2)

Breathing Exercise Application Group

EXPERIMENTAL

Patients in the breathing exercise practice group will have breathing exercise practice for 15-20 minutes half an hour before the angiography procedure. The breathing exercise application will be applied to the patients face to face by the researcher.

Behavioral: Experimental: Breathing Exercise Application Group

Control group

NO INTERVENTION

There will be no intervention for individuals in this group.

Interventions

The Effect of Breathing Exercise on Anxiety, Pain and Life Findings in Patients Undergoing Coronary Angiography

Breathing Exercise Application Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing coronary angiography for the first time
  • Over 18 years of age
  • No respiratory distress
  • No problems with communication
  • Volunteering to be included in the study.

You may not qualify if:

  • Taking any medication to suppress anxiety symptoms
  • Patients undergoing emergency coronary angiography and/or patients complaining of chest pain
  • Patients on antihypertensive treatment before the procedure due to hypertension
  • Patients who underwent emergency intervention during coronary angiography, surgical procedure and intensive care unit for follow-up were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaraş Istiklal Universty

Kahramanmaraş, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sevinç Meşe

    Kahramanmaraş İstiklal University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The post-test measurements will be collected by a nurse working in the angiography ward who is not connected with the study.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 13, 2024

First Posted

September 19, 2024

Study Start

September 18, 2024

Primary Completion

November 25, 2024

Study Completion

November 25, 2024

Last Updated

December 5, 2024

Record last verified: 2024-12

Locations