Preparing fathers for a child's heart surgery: reducing anxiety and building confidence
| ISRCTN | ISRCTN11662988 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11662988 |
| Sponsor | Shahid Beheshti University of Medical Sciences |
| Funder | Shahid Beheshti University of Medical Sciences |
- Submission date
- 13/11/2025
- Registration date
- 18/11/2025
- Last edited
- 18/11/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
When a child needs heart surgery, it is an extremely stressful time for the whole family. While a lot of support is often available for mothers, fathers are frequently overlooked. Fathers face their own unique challenges, including feeling left out of medical conversations while bearing the weight of family decisions. This study aimed to test a special preparation program designed specifically for fathers. The goal was to see if providing fathers with clear information and support before their child's surgery could help reduce their anxiety and increase their confidence in their ability to care for their child.
Who can participate?
The study involved fathers of children (aged 3 to 7 years) who were scheduled for open-heart surgery at the participating hospital. To take part, fathers needed to be living with their child and spouse, be able to speak Farsi, and have no severe visual, hearing, or speech problems. Fathers who were already experiencing very high levels of anxiety or very low confidence were not eligible, as the study was designed to see if the program could prevent these feelings from developing or worsening.
What does the study involve?
Fathers who agreed to participate were divided into two groups by a method based on their child's hospital file number.
The intervention group took part in a special preparation program before their child's surgery. This program included:
1. A tour of the operating room and intensive care unit.
2. Educational sessions explaining their child's heart condition, the surgery, and what to expect afterwards.
3. Group meetings with other fathers who had been through a similar experience.
4. Learning simple stress-management techniques.
5. Receiving pamphlets and other written information.
The control group received the hospital's standard care, which included routine pre-operative information from nurses, but did not receive the special tours, group sessions, or extra educational materials.
All fathers were asked to complete short questionnaires about their anxiety and confidence levels at three different times: before any preparation, immediately after the preparation program, and when their child was discharged from the hospital.
What are the possible benefits and risks of participating?
For fathers in the intervention group, the possible benefits included feeling less anxious, more prepared, and more confident in supporting their child and family during a difficult time. There were no expected physical risks from participating. The main potential risk was emotional, as talking about the surgery and visiting clinical areas could be temporarily stressful. However, the program was designed and led by healthcare professionals to provide support in a safe and helpful way.
Where is the study run from?
Children’s Medical Center Hospital in Tehran (Iran)
When is the study starting and how long is it expected to run for?
January 2024 to March 2025
Who is funding the study?
Shahid Beheshti University of Medical Sciences (Iran)
Who is the main contact?
Dr Hadi Khoshab, Hadikhoshab@gmail.com
Contact information
Scientific, Public, Principal investigator
Department of Nursing, School of Nursing and Midwifery
Bam University of Medical Sciences
Bam
7616767687
Iran
| Phone | +98 (0)9132425700 |
|---|---|
| Hadikhoshab@gmail.com |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Case-control study |
| Scientific title | Exploring the role of fathers’ preoperative preparation in reducing anxiety and enhancing self-efficacy before pediatric open-heart surgery |
| Study objectives | Parents of children undergoing cardiac surgery face significant anxiety. This study evaluated a preoperative preparation program for fathers of children (aged 3–7 years) having open-heart surgery. |
| Ethics approval(s) |
Approved 06/12/2023, Research Ethics Committees of the School of Pharmacy and Nursing and Midwifery (Shahid Beheshti University of Medical Sciences, Tehran, 655678958, Iran; +98 (0)9132425700; Zamaniroya146@gmail.com), ref: IR.SBMU.PHARMACY.REC.1401.193 |
| Health condition(s) or problem(s) studied | Anxiety and self-efficacy of fathers of children aged 3 to 7 years undergoing open-heart surgery due to CHD |
| Intervention | In this semi-experimental study, 60 fathers were randomly assigned to an intervention group (n=30) receiving structured preparation (hospital tours, group counseling, education) or a control group (n=30) receiving standard care. Anxiety and self-efficacy were measured using the VAS-A and PSAM at three timepoints. |
| Intervention type | Other |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 12/03/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 30 Years |
| Upper age limit | 50 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Having children with CHD between the ages of 3 and 7 years as candidates for open-heart surgery 2. Able to speak Farsi 3. Not having visual issues, auditory issues, or speech problems 4. Low score in the anxiety and self-efficacy scale 5. Living with a spouse and child in a house |
| Key exclusion criteria | 1. Discharge or death of the child 2. Withdrawal of the father from the study |
| Date of first enrolment | 01/01/2024 |
| Date of final enrolment | 12/02/2025 |
Locations
Countries of recruitment
- Iran
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
17/11/2025: Study's existence confirmed by the Research Ethics Committees of the School of Pharmacy and Nursing and Midwifery, Shahid Beheshti University of Medical Sciences.
