The Effect of Quilling Exercise Applied Before Cardiac Catheterization and Angiography

NCT06755931 | Active Not Recruiting DMC

• 1 other identifier: NEU2024YLTez(2)
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The heart is one of the most important organs of the body. Any defect in the heart or blood vessels can cause serious problems and include a number of health problems that reduce the quality of life. Despite recently developing technologies, heart diseases are one of the important causes of morbidity and mortality in children. He contributed to the determination of the treatment plan in more than 84% of the cases in cardiac catheterization and angiography, which are widely used in the diagnosis and treatment of congenital heart diseases. Since the cardiac catheterization and angiography procedure consists of a process, the nurse plays an important role in shortening the treatment time, increasing the comfort level, and reducing anxiety and fear as a result of the correct interventions that follow the patient before, during and after the procedure. For this reason, the nurse must be equipped and have sufficient knowledge in the field in the nursing care and interventions applied to patients for whom angiography is planned. Since cardiac catheterization and angiography is an invasive procedure and requires surgical intervention, it can cause negative situations such as fear, pain and anxiety in children. Since it is thought that it can be effective in reducing fear and anxiety in children through the Quilling Set activity planned to be implemented in the study in order to reduce the negative situations caused by the procedure, it is thought that the study will make a positive contribution to children and parents in physical and psychological terms.

Conditions

Children; Cardiac Catheterization

Keywords

child; Cardiac catheterization; fear; anxiety; nursing

Outcome Measures

Primary Outcomes (3)

• Introductory Information Form

  In the introductory information form prepared by the researcher in line with the literature; There are a total of 11 questions, such as the child's age, gender, number of siblings, family type, place of residence, family income level, mother's age, mother's education, mother's profession, and hospitalization status of the child.

  During the children's first hospitalization, the researcher will fill out an introductory information form. (Approximately 5 minute)

• State Anxiety Inventory for Children (STAI-C)

  This scale was developed by Spielberger in 1973 to evaluate children's state and trait anxiety and is in a self-report form. It was translated into Turkish by Özusta and an application study was carried out. As a result of some procedures, the scale was turned into 2 separate scales containing a total of 40 items (20 state and 20 trait anxiety items). Although the validity and reliability of the scale has been done for children aged 9-12, the scale can be used until the age of 17 because it is difficult for children over the age of 12 to understand the adult anxiety scale. It has also been seen in the literature that it is used in all school-age children who can read. In the STAI-C, children are asked to mark one of three options regarding how they feel "at that moment". The scale aims to evaluate emotions related to state anxiety such as tension, irritability, rush, and uneasiness.The highest score that can be obtained from the STAI-C is 60 and and the lowest score is 20.

  It will be filled out by the researcher, child and parent before and after the procedure (Approximately 10 minute).

• Child Fear Scale

  This scale was used by McMurtry et al. to measure children's anxiety levels. It was developed by in 2011. The scale was developed by Gerçeker et al. in 2018. It has been validated in Turkish by and is aimed at children aged 5-10. However, it is stated that it can be used up to the age of 12. Facial muscle changes in fearful expressions were drawn by a graphic designer based on photographs of frightened faces. The scale can be used by the family, the child or the researcher to evaluate children. In this scale, the child is shown a scale containing five facial expressions rated between 0 and 4 points. While 0 indicates no fear and anxiety; 4 shows the highest fear and anxiety. These are: "0" neutral expression (no anxiety), "1" very little fear (very little anxiety), "2" some fear (some anxiety), "3" more fear (more anxiety), "4" the most fear possible. It is considered high fear (severe anxiety).

  It will be filled out by the researcher, child and parent before and after the procedure (Approximately 10 minute).

Study Arms (2)

Quilling Group

EXPERIMENTAL

Behavioral: quilling set

Control

ACTIVE COMPARATOR

Behavioral: Control

Interventions

quilling set BEHAVIORAL

After the intervention group is determined in randomization, half an hour before the cardiac catheterization and angiography procedure, without premedication treatment, the researcher will be asked to choose 2 animal and plant figures, samples of which have been previously made, through a quilling set, in cooperation with the researcher. It will be done with the child in a 15-20 minute period, accompanied by the researcher, with 2 figures chosen by the child. With the opportunity for the child to choose the color and figure he/she wants, the child will be at the center of the work. The figure will be given as a gift to the child and the survey forms will be filled out again 5 minutes after the application, before the premedication treatment. In order to prevent bias in the research, the descriptive information form and fear and anxiety scales will be taken by the evaluation of three people: the researcher, the parent and the child.

Quilling Group

Control BEHAVIORAL

Before the procedure, while the child is in the patient room, the details of the research will be explained, their consent will be obtained and the Introductory Information Form will be filled in by the parent, and the Fear Scale and State Anxiety Scale will be filled in by the child and the parent. After the control group is determined in randomization, the researcher will apply the posttest without premedication treatment half an hour before the cardiac catheterization and angiography procedure. No separate intervention will be applied. In accordance with ethical principles, after the procedure, 2 Quilling figures chosen by the control group and the child will be prepared with the help of the researcher, and the prepared figures will be gifted to the child.

Control

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Are between the ages of 9-12,
• Able to read and write Turkish,
• Accompanied by their parents,
• Having no mental disabilities or communication problems,
• No visual or hearing impairment,
• Those who have not had cardiac catheterization or angiography before,
• Children who are willing to participate in the research will be included in the research.

You may not qualify if:

• Those who have any body function deficiency that prevents them from playing quilling,
• Those who did not complete the quilling initiative and wanted to quit the study.

Sponsors & Collaborators

• Semra Kose: lead

Study Sites (1)

Necmettin Erbakan University

Konya, Meram, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor (PhD, RN)

Model Details: The study was planned as a pre-test, post-test parallel group (intervention-control), randomized controlled experimental research type.

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: January 1, 2025
• Study Start: December 9, 2024
• Primary Completion: March 15, 2025
• Study Completion: June 15, 2025
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)