NCT05160935

Brief Summary

This research; The aim of this study was to evaluate the effect of the pre-procedural education given to the patients undergoing coronary angiography on the anxiety level and vital signs of the patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

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

November 17, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
16 days until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

August 19, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

November 17, 2021

Last Update Submit

August 18, 2022

Conditions

Outcome Measures

Primary Outcomes (6)

  • To accept the hypothesis that "the education given to the patients who will undergo coronary angiography has an effect on reducing the anxiety levels of the patients".

    "State-Trait Anxiety Inventory" will be applied to the patient in the experimental group before the coronary angiography procedure. Then, coronary angiography information training will be given using the Coronary Angiography Training Guide tool. After the angiography procedure, "State-Trait Anxiety Inventory" will be applied again. State-Trait Anxiety Inventory: The inventory includes two separate scales consisting of a total of forty items (twenty items in each scale). For both scales; 0-19 points (absent), 20-39 points (mild), 40-59 points (moderate), 60-79 points (severe), 80 points and above are considered as very severe panic. Both scales have direct and reversed statements. In the State Anxiety Inventory, there are ten in total (1, 2, 5, 8, 10, 11, 15, 16, 19, 20) and in the Trait Anxiety Inventory seven (21, 26, 27, 30, 33, 36, 39) There are reversed statements.

    8 weeks

  • To accept the hypothesis that "the education given to the patients who will undergo coronary angiography has a positive effect on the blood pressure (mm-Hg) level, one of the vital signs values of the patients".

    The blood pressure (mm-Hg) of the patient in the experimental group before the coronary angiography procedure will be measured and recorded by the nurse. Afterwards, coronary angiography information training will be given audio-visual using the Coronary Angiography Training Guide tool. The patient will be prepared for the coronary angiography procedure. After the coronary angiography procedure, the patient's blood pressure (mm-Hg) will be measured and recorded by the nurse. Pre- and post-procedure scores will be evaluated using appropriate statistical methods. The blood pressure value that is considered normal is 120/80 mm-Hg, with an upper limit of 139/89 mm-Hg.

    8 weeks

  • To accept the hypothesis that "the education given to the patients who will undergo coronary angiography has a positive effect on the heart rate (beats/min) level, which is one of the vital signs values of the patients".

    Before the coronary angiography procedure of the patient in the experimental group, the heart rate (beats/min) will be measured and recorded by the nurse. Afterwards, coronary angiography information training will be given as audio-visual using the Coronary Angiography Training Guide tool. The patient will be prepared for the coronary angiography procedure. After the coronary angiography procedure, the patient's heart rate (beats/min) will be measured and recorded by the nurse. Pre- and post-procedure scores will be evaluated with appropriate statistical methods. The normal range of pulse rate; 60-100 beats/min.

    8 weeks

  • To accept the hypothesis that "the education given to the patients who will undergo coronary angiography has a positive effect on the vital signs of the patients, the respiratory rate (respiratory rate/min)".

    The respiratory rate (respiratory rate/min) of the patient in the experimental group before the coronary angiography procedure will be measured and recorded by the nurse. Later, coronary angiography information training will be given audio-visual using the Coronary Angiography Training Guide tool. The patient will be prepared for the coronary angiography procedure. After the coronary angiography procedure, the patient's respiratory rate (respiratory rate/min) will be measured and recorded by the nurse. Pre- and post-procedure scores will be evaluated using appropriate statistical methods. The normal range of respiratory rate; 12-20 ventilation/min.

    8 weeks

  • To accept the hypothesis that "the education given to the patients who will undergo coronary angiography has a positive effect on the vital signs values of the patients and the body temperature (°C) level".

    Before the coronary angiography procedure of the patient in the experimental group, the body temperature (°C) will be measured and recorded by the nurse. Afterwards, coronary angiography information training will be given as audio-visual using the Coronary Angiography Training Guide tool. The patient will be prepared for the coronary angiography procedure. After the coronary angiography procedure, the patient's body temperature (°C) will be measured and recorded by the nurse. Pre- and post-procedure scores will be evaluated using appropriate statistical methods. The range of body temperature considered normal; 36°C - 38°C

    8 weeks

  • To accept the hypothesis that "the education given to the patients who will undergo coronary angiography has a positive effect on the oxygen saturation (SpO2) level, one of the vital signs values of the patients".

    Before the coronary angiography procedure of the patient in the experimental group, the oxygen saturation (SpO2) will be measured and recorded by the nurse. Afterwards, coronary angiography information training will be given as audio-visual using the Coronary Angiography Training Guide tool. The patient will be prepared for the coronary angiography procedure. After the patient's coronary angiography procedure, the oxygen saturation (SpO2) will be measured and recorded by the nurse. Pre- and post-procedure scores will be evaluated using appropriate statistical methods. Oxygen saturation (SpO2) is within the considered normal range; 93-100 SpO2.

    8 weeks

Study Arms (1)

Coronary Angiography Training Manual

EXPERIMENTAL

It is the form prepared by the researchers in line with the literature information and the opinion of the specialist physician was taken. It contains information about coronary artery disease, what to do before coronary angiography procedure and what kind of situations await individuals after the procedure.

Behavioral: Education

Interventions

EducationBEHAVIORAL

Each patient will be informed about the study, and written consent will be obtained from patients who agree to participate in the study, explaining the purpose and duration of the study. A Patient Identification Form will be filled, the patient's vital signs will be evaluated, and the State-Trait Anxiety Inventory will be administered to the patient. Before the coronary angiography procedure, the patients in the experimental group will be trained by the researchers using the training booklet. Trait Anxiety Inventory will be re-administered to the patients after the procedure. Vital signs of patients will be monitored. In the control group; In line with the information in the patient consent form before the coronary angiography procedure, verbal information will be given about the coronary angiography procedure within the scope of the routine procedure in the clinic. After the procedure, the State-Trait Anxiety Inventory will be applied again. Vital signs will be taken.

Coronary Angiography Training Manual

Eligibility Criteria

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

You may qualify if:

  • Having at least literate education level,
  • years old or older,
  • No communication problems,
  • Does not have mental or psychiatric disease,
  • Agreeing to participate in the study voluntarily,
  • Individuals who will undergo coronary angiography for the first time.

You may not qualify if:

  • Being illiterate
  • Being under the age of 18
  • Having any communication problem,
  • Having mental or psychiatric disease,
  • Not wanting to participate in the study,
  • Individuals who have undergone coronary angiography before.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskişehir Şehir Hastanesi

Eskişehir, 26020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Sevil PAMUK CEBECİ

    sevil.pamukcebeci@ogu.edu.tr

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Planning the Simple Randomization Method; Since the individuals in the sample group will share the same environment, it is created by separating different days for the experimental group and different days for the control group. It is planned to divide the sample as the control group on odd days and the experimental group on even days. In the selection of both groups, attention will be paid to the similarity of individual characteristics such as age, gender and educational status.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst.Prof.Dr.

Study Record Dates

First Submitted

November 17, 2021

First Posted

December 16, 2021

Study Start

January 1, 2022

Primary Completion

June 30, 2022

Study Completion

July 30, 2022

Last Updated

August 19, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations