Congenital Heart DiseaseNCT07575451
Empowering Families in Pediatric Cardiovascular Surgery: A RAM-Based Approach
A study testing RAM-based Nursing Empowerment Program and Routine Care and Educational Booklet in people with Congenital Heart Disease and Postoperative Care, run by Cukurova University at 3 sites in Turkey (Türkiye).
Trial summary
The purpose of this clinical trial is to learn about the effects of a nursing support program designed for families of children aged 1 to 3 years who have undergone heart surgery. This program aims to improve parents' caregiving skills and support the healthy growth of their children. Read more about this study
- Who is it for?
- Ages 1 year to 3 years
- Conditions the study is for
- Congenital Heart Disease, Postoperative Care, Child Development
- What is being tested?
- RAM-based Nursing Empowerment Program and Routine Care and Educational Booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 15 Jun 2026to 15 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Families who agree to participate in the study and sign the informed consent form.
- Families of children aged 1-3 years in the preoperative period who are scheduled to undergo cardiac surgery due to congenital heart disease.
- Families who do not speak or read Turkish but will undergo cardiac surgery due to congenital heart disease will also be included in the study with the assistance of an interpreter.
- Families who are over 18 years of age and have access to a mobile phone or internet at home.
Who cannot join
- Exclusion criteria include the presence of additional congenital malformations, dysmorphic syndromes, chromosomal or endocrine disorders, severe infection, hypothyroidism, or any similar conditions that could lead to growth and developmental delay in the child, alongside congenital heart disease
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Şenay Çetinkaya, Prof. Dr. contact
Turkey (Türkiye)3 sites
Adana City Training and Research Hospital
Adana, Adana, 01300
Kübra Türker, PhD Student, +905357416538, kubrakadah@hotmail.com
Cukurova University
Adana, Adana, 01330
Kübra Türker, PhD, +905357416538, kubrakadah@hotmail.com
Şenay Çetinkaya, Prof. Dr., +905353492958, scetinkaya@cu.edu.tr
Cukurova University
Adana, Adana, 01330
About this study
Official title: Evaluation of a Nursing Program Based on Roy's Adaptation Model for Empowering Families of Children Aged 1 to 3 Years Post-Cardiac Surgery
The purpose of this clinical trial is to learn about the effects of a nursing support program designed for families of children aged 1 to 3 years who have undergone heart surgery. This program aims to improve parents' caregiving skills and support the healthy growth of their children.
The primary questions the study aims to answer are:
Read more
Does the nursing program positively affect the physical growth of children, such as their height and weight?
Does the program improve children's scores on general development tests (Denver II)?
Do parents' attitudes toward child feeding and their confidence in parenting skills increase?
Researchers will divide participants into two groups:
Experimental Group: Families who participate in the nursing education program and receive an informative booklet.
Control Group: Families who only receive an informative booklet and continue with routine hospital follow-ups.
The researchers will compare these two groups to see if participating in the nursing program leads to better results for the children's development and the families' skills.
Participants will be asked to:
Attend 5 different education and counseling sessions, starting one week before surgery and continuing until the child reaches 1 year of follow-up.
Meet with the researcher at specific intervals (at 1, 2, 3, 6, 9, and 12 months) for one year to monitor the child's development (height, weight, head circumference) and skills.
Complete surveys regarding child feeding attitudes and parenting skills at the 6th and 12th month follow-ups.
Read the detailed description
Detailed Description
- Study Rationale and Objectives This study is designed as an experimental research project to evaluate the effectiveness of a nursing empowerment program based on Roy's Adaptation Model (RAM). The primary objective is to empower the families of children aged 1 to 3 years who have undergone cardiovascular surgery and to examine the impact of this empowerment on the children's growth, development, and parental outcomes.
- Study Design and Setting Design: Prospective, randomized controlled experimental trial.Study Sites: Çukurova University Faculty of Medicine Balcalı Hospital and Adana City Training and Research Hospital (Pediatric Cardiovascular Surgery Departments).Timeframe: June 15, 2026 - June 15, 2027.
- Participants and Randomization Universe: All families of children aged 1-3 years undergoing heart surgery at the specified hospitals during the study period. Sample Size: Calculated using G*Power 3.1.9.2 (Effect size $f = 0.25$, $\alpha = 0.05$, power $= 0.80$).Randomization: Participants will be assigned to either the Experimental Group or the Control Group using a simple random number table. Homogeneity between groups will be verified via Chi-square and t-tests regarding baseline demographics (age, education, income).
- Interventions Experimental Group (Empowerment Program):Families will participate in the "RAM-Based Family Empowerment Program."The program consists of 5 structured sessions:Pre-operative (1 week before): Preparation and baseline assessment.Post-operative (First day in ward): Post-op counseling and support.1st Month Follow-up: First follow-up education session.2nd Month Follow-up: Second follow-up education session.3rd Month Follow-up: Final structured education session.Educational materials include a RAM-based booklet, brochures, and visual aids (videos/posters) focusing on physiological, self-concept, role function, and interdependence modes.Control Group:Families will receive routine hospital care.A "RAM-Based Post-Cardiac Surgery Family Empowerment Booklet" will be provided as a baseline resource, but no structured counseling sessions will be conducted.
- Data Collection and Follow-up Schedule All measurements and evaluations throughout the study will be performed face-to-face by the same researcher to ensure data consistency and reliability. The data collection process begins with a Baseline (Pre-operative) assessment conducted one week before surgery, where all tools-including the Sociodemographic and Anthropometric Data Form, the RAM-Based Assessment Form, the Denver II Developmental Screening Test, the Maternal Attitudes Toward Feeding Process Scale (MAFPS), and the Parental Self-Efficacy Scale-are administered to the participants. Following the intervention, a structured follow-up schedule is implemented to monitor the child's physical growth and the family's adaptation process. During the 1st, 2nd, 3rd, and 9th months post-operatively, researchers will perform anthropometric measurements (including height, weight, head circumference, and BMI) and the Denver II test to track developmental progress. At the 6th and 12th-month follow-ups, a comprehensive full assessment will be conducted; this includes a repeat of all anthropometric measurements and the Denver II test, along with the re-administration of the MAFPS for mothers and the Parental Self-Efficacy Scale for both mothers and fathers to evaluate long-term parental outcomes and the sustained effectiveness of the empowerment program.
- Pilot Study A pilot study will be conducted with 10 families to test the clarity of the educational content and the duration of data collection tools. Pilot participants will be excluded from the main study analysis.
- Statistical Analysis Data will be analyzed using IBM SPSS 28.Descriptive Statistics: Mean, standard deviation, frequency, and percentage.Group Comparisons: Independent t-test or Mann-Whitney U test.Pre-Post Comparisons: Paired t-test or Wilcoxon test.Multi-Factorial Analysis: Repeated Measures ANOVA to evaluate the change over time between groups.Significance Level: $p < 0.05$.
- Ethical Considerations Ethical approval has been obtained from the Çukurova University Clinical Research Ethics Committee. Written informed consent will be obtained from all participating families. Confidentiality and anonymity of participant data will be strictly maintained. No physical or psychological risks are anticipated for the participants.
- Conditions
- Congenital Heart Disease, Postoperative Care, Child Development, Roy Adaptation Model-based Nursing Empowerment Program
- Being tested
- RAM-based Nursing Empowerment Program, Routine Care and Educational Booklet
- Keywords
- Congenital Heart Disease, Cardiac Surgery, Postoperative Care, Nursing Support Program
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAM-based Nursing Empowerment ProgramBehavioural
RAM-based nursing empowerment program for families of children (ages 1-3) after heart surgery. Includes 5 structured sessions focusing on family empowerment, coping mechanisms, and child development.
Routine Care and Educational BookletOther
Families in the control group will receive routine care and an educational booklet titled "Family Empowerment Booklet After Cardiac Surgery Based on Roy Adaptation Model". The booklet provides information on care processes and coping strategies.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Families of children aged 1-3 who participate in the RAM-based nursing empowerment program Receives: Behavioral: RAM-based Nursing Empowerment Program |
| Control Group | Active comparator | Families who receive routine care and the informative booklet Receives: Other: Routine Care and Educational Booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Developmental Screening Test II (Denver II)
A performance-based test designed to screen children from birth to 72 months for developmental delays. It evaluates 125 items across four domains: Personal-social, fine motor-adaptive, language, and gross motor skills. Results are categorized as Normal, Suspected, or Abnormal based on age-standardized performance.
Measured: At months 1, 2, 3, 6, 9, and 12 after the intervention
Secondary outcomes (3)
Parental Self-Efficacy Scale (1-3 Years)
A 51-item scale measuring parental self-efficacy in seven domains: Emotional Competence, Responsive Sensitivity, Protection, Discipline, Play, Teaching, and Daily Routines/Care. Scores range from 51 to 255; higher scores indicate stronger parental self-efficacy.
Measured: Month 6 and Month 12 post-intervention
Child Growth Parameters (Anthropometric Z-Scores)
Growth parameters including height, weight, and Body Mass Index (BMI). Standardized Z-scores (Standard Deviation Scores - SDS) will be calculated using WHO Anthro software based on Turkish growth percentiles (Neyzi et al., 2008). Malnutrition is defined as Z-scores below -2 SD.
Measured: At months 1, 2, 3, 6, 9, and 12 after the intervention
Feeding Process Maternal Attitude Scale (FPMAS)
This 27-item, 5-point Likert-type scale measures maternal attitudes during the feeding process. It includes five sub-dimensions: Negative Mood During Meals, Attitudes Toward Inadequate/Unbalanced Nutrition, Negative Feeding Strategies, Forced Feeding, and Reaction to Others' Opinions. Total scores range from 27 to 135; higher scores indicate more problematic or negative maternal feeding attitudes.
Measured: Month 6 and Month 12 post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1: Experimental Group Arm Type: Experimental Arm Label: Nursing Empowerment Program Group Description: Families of children aged 1-3 years who have undergone cardiac surgery. This group receives a nursing empowerment program based on the Roy Adaptation Model (RAM) consisting of 5 sessions (initial assessment, 4 counseling sessions, and final assessment). Arm 2: Control Group Arm Type: No Intervention (veya "Active Comparator") Arm Label: Routine Care and Booklet Group Description: Families of children aged 1-3 years who have undergone cardiac surgery. This group receives routine hospital follow-ups and an informative booklet based on the Roy Adaptation Model but does not participate in the structured nursing empowerment sessions.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Türker, Cukurova University
- Investigators
- Şenay Çetinkaya, Prof. Dr., Principal investigator, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575451
- Sponsor's protocol ID
- 154-70
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect the privacy of participants and due to ethical committee restrictions.
Publications
Demirsoy Horta G, Aksu H, Ozsoy S. Use of Roy's Adaptation Model in women's adaptation to the postpartum period. Ege University Faculty of Nursing Journal (Ege Universitesi Hemsirelik Fakultesi Dergisi). 2017; 33(1):180-190.
Alimohammadi N, Maleki B, Shahriari M, Chitsaz A. Effect of a care plan based on Roy adaptation model biological dimension on stroke patients' physiologic adaptation level. Iran J Nurs Midwifery Res. 2015 Mar-Apr;20(2):275-81.
PubMed 25878708Uzun S. Sister Callista Roy: Adaptation Model. In: Karadag A, Caliskan N, Baykara ZG (eds). Nursing Theories and Models. Istanbul: Akademi Basin ve Yayincilik. 2017: 382-397.
Goudarzi F, Khadivzadeh T, Ebadi A, Babazadeh R. Women's interdependence after hysterectomy: a qualitative study based on Roy adaptation model. BMC Womens Health. 2022 Feb 13;22(1):40. doi: 10.1186/s12905-022-01615-2.
PubMed 35152900Erol Ursavas F, Karayurt O. Effects of a Roy's Adaptation Model-Guided Support Group Intervention on Sexual Adjustment, Body Image, and Perceived Social Support in Women With Breast Cancer. Cancer Nurs. 2021 Nov-Dec 01;44(6):E382-E394. doi: 10.1097/NCC.0000000000000854.
PubMed 32657901Elibol F, Magden D, Alpar R. Validity and reliability of the parental self-efficacy scale (1-3 years). Bulletin of Community Medicine (Toplum Hekimligi Bulteni). 2007;26(3):25-31.
Dilsiz H, Dag I. Feeding Process Maternal Attitude Scale (FPMAS): Development, Validity and Reliability Study. Turk J Pediatr Dis (Turkiye Cocuk Hastaliklari Dergisi). 2020; 14:7-15.
Yalaz K, Anlar B, Bayoglu B. Denver II developmental screening test "Turkish standardization". Ankara: Developmental Child Neurology Association. 2010; 11-26.
Neyzi O, Bundak R, Gokcay G, Gunoz H, Furman A, Darendeliler F, Bas F. Reference Values for Weight, Height, Head Circumference, and Body Mass Index in Turkish Children. J Clin Res Pediatr Endocrinol. 2015 Dec;7(4):280-93. doi: 10.4274/jcrpe.2183.
PubMed 26777039
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Nursing Program Based on Roy's Adaptation Model for Empowering Families of Children Aged 1 to 3 Years Post-Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07575451
- Acronym / sponsor ID
- 154-70
- Conditions
- Congenital Heart Disease, Postoperative Care, Child Development, Roy Adaptation Model-based Nursing Empowerment Program
- Keywords
- Congenital Heart Disease, Cardiac Surgery, Postoperative Care, Nursing Support Program
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to learn about the effects of a nursing support program designed for families of children aged 1 to 3 years who have undergone heart surgery. This program aims to improve parents' caregiving skills and support the healthy growth of their children.
The primary questions the study aims to answer are:
Does the nursing program positively affect the physical growth of children, such as their height and weight?
Does the program improve children's scores on general development tests (Denver II)?
Do parents' attitudes toward child feeding and their confidence in parenting skills increase?
Researchers will divide participants into two groups:
Experimental Group: Families who participate in the nursing education program and receive an informative booklet.
Control Group: Families who only receive an informative booklet and continue with routine hospital follow-ups.
The researchers will compare these two groups to see if participating in the nursing program leads to better results for the children's development and the families' skills.
Participants will be asked to:
Attend 5 different education and counseling sessions, starting one week before surgery and continuing until the child reaches 1 year of follow-up.
Meet with the researcher at specific intervals (at 1, 2, 3, 6, 9, and 12 months) for one year to monitor the child's development (height, weight, head circumference) and skills.
Complete surveys regarding child feeding attitudes and parenting skills at the 6th and 12th month follow-ups.
Detailed description
Detailed Description
- Study Rationale and Objectives This study is designed as an experimental research project to evaluate the effectiveness of a nursing empowerment program based on Roy's Adaptation Model (RAM). The primary objective is to empower the families of children aged 1 to 3 years who have undergone cardiovascular surgery and to examine the impact of this empowerment on the children's growth, development, and parental outcomes.
- Study Design and Setting Design: Prospective, randomized controlled experimental trial.Study Sites: Çukurova University Faculty of Medicine Balcalı Hospital and Adana City Training and Research Hospital (Pediatric Cardiovascular Surgery Departments).Timeframe: June 15, 2026 - June 15, 2027.
- Participants and Randomization Universe: All families of children aged 1-3 years undergoing heart surgery at the specified hospitals during the study period. Sample Size: Calculated using G*Power 3.1.9.2 (Effect size $f = 0.25$, $\alpha = 0.05$, power $= 0.80$).Randomization: Participants will be assigned to either the Experimental Group or the Control Group using a simple random number table. Homogeneity between groups will be verified via Chi-square and t-tests regarding baseline demographics (age, education, income).
- Interventions Experimental Group (Empowerment Program):Families will participate in the "RAM-Based Family Empowerment Program."The program consists of 5 structured sessions:Pre-operative (1 week before): Preparation and baseline assessment.Post-operative (First day in ward): Post-op counseling and support.1st Month Follow-up: First follow-up education session.2nd Month Follow-up: Second follow-up education session.3rd Month Follow-up: Final structured education session.Educational materials include a RAM-based booklet, brochures, and visual aids (videos/posters) focusing on physiological, self-concept, role function, and interdependence modes.Control Group:Families will receive routine hospital care.A "RAM-Based Post-Cardiac Surgery Family Empowerment Booklet" will be provided as a baseline resource, but no structured counseling sessions will be conducted.
- Data Collection and Follow-up Schedule All measurements and evaluations throughout the study will be performed face-to-face by the same researcher to ensure data consistency and reliability. The data collection process begins with a Baseline (Pre-operative) assessment conducted one week before surgery, where all tools-including the Sociodemographic and Anthropometric Data Form, the RAM-Based Assessment Form, the Denver II Developmental Screening Test, the Maternal Attitudes Toward Feeding Process Scale (MAFPS), and the Parental Self-Efficacy Scale-are administered to the participants. Following the intervention, a structured follow-up schedule is implemented to monitor the child's physical growth and the family's adaptation process. During the 1st, 2nd, 3rd, and 9th months post-operatively, researchers will perform anthropometric measurements (including height, weight, head circumference, and BMI) and the Denver II test to track developmental progress. At the 6th and 12th-month follow-ups, a comprehensive full assessment will be conducted; this includes a repeat of all anthropometric measurements and the Denver II test, along with the re-administration of the MAFPS for mothers and the Parental Self-Efficacy Scale for both mothers and fathers to evaluate long-term parental outcomes and the sustained effectiveness of the empowerment program.
- Pilot Study A pilot study will be conducted with 10 families to test the clarity of the educational content and the duration of data collection tools. Pilot participants will be excluded from the main study analysis.
- Statistical Analysis Data will be analyzed using IBM SPSS 28.Descriptive Statistics: Mean, standard deviation, frequency, and percentage.Group Comparisons: Independent t-test or Mann-Whitney U test.Pre-Post Comparisons: Paired t-test or Wilcoxon test.Multi-Factorial Analysis: Repeated Measures ANOVA to evaluate the change over time between groups.Significance Level: $p < 0.05$.
- Ethical Considerations Ethical approval has been obtained from the Çukurova University Clinical Research Ethics Committee. Written informed consent will be obtained from all participating families. Confidentiality and anonymity of participant data will be strictly maintained. No physical or psychological risks are anticipated for the participants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arm 1: Experimental Group Arm Type: Experimental Arm Label: Nursing Empowerment Program Group Description: Families of children aged 1-3 years who have undergone cardiac surgery. This group receives a nursing empowerment program based on the Roy Adaptation Model (RAM) consisting of 5 sessions (initial assessment, 4 counseling sessions, and final assessment). Arm 2: Control Group Arm Type: No Intervention (veya "Active Comparator") Arm Label: Routine Care and Booklet Group Description: Families of children aged 1-3 years who have undergone cardiac surgery. This group receives routine hospital follow-ups and an informative booklet based on the Roy Adaptation Model but does not participate in the structured nursing empowerment sessions.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: RAM-based Nursing Empowerment ProgramFamilies of children aged 1-3 who participate in the RAM-based nursing empowerment program |
| Control Group | Active comparator | Other: Routine Care and Educational BookletFamilies who receive routine care and the informative booklet |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Families who agree to participate in the study and sign the informed consent form.
- Families of children aged 1-3 years in the preoperative period who are scheduled to undergo cardiac surgery due to congenital heart disease.
- Families who do not speak or read Turkish but will undergo cardiac surgery due to congenital heart disease will also be included in the study with the assistance of an interpreter.
- Families who are over 18 years of age and have access to a mobile phone or internet at home.
Key exclusion criteria (1 listed)
- Exclusion criteria include the presence of additional congenital malformations, dysmorphic syndromes, chromosomal or endocrine disorders, severe infection, hypothyroidism, or any similar conditions that could lead to growth and developmental delay in the child, alongside congenital heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAM-based Nursing Empowerment ProgramRAM-based nursing empowerment program for families of children (ages 1-3) after heart surgery. Includes 5 structured sessions focusing on family empowerment, coping mechanisms, and child development. | Behavioural | Experimental Group |
| Routine Care and Educational BookletFamilies in the control group will receive routine care and an educational booklet titled "Family Empowerment Booklet After Cardiac Surgery Based on Roy Adaptation Model". The booklet provides information on care processes and coping strategies. | Other | Control Group |
Primary outcome
Developmental Screening Test II (Denver II)
Time frame: At months 1, 2, 3, 6, 9, and 12 after the intervention
A performance-based test designed to screen children from birth to 72 months for developmental delays. It evaluates 125 items across four domains: Personal-social, fine motor-adaptive, language, and gross motor skills. Results are categorized as Normal, Suspected, or Abnormal based on age-standardized performance.
3 secondary outcomes
Parental Self-Efficacy Scale (1-3 Years)
Time frame: Month 6 and Month 12 post-intervention
Child Growth Parameters (Anthropometric Z-Scores)
Time frame: At months 1, 2, 3, 6, 9, and 12 after the intervention
Feeding Process Maternal Attitude Scale (FPMAS)
Time frame: Month 6 and Month 12 post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- BackgroundDemirsoy Horta G, Aksu H, Ozsoy S. Use of Roy's Adaptation Model in women's adaptation to the postpartum period. Ege University Faculty of Nursing Journal (Ege Universitesi Hemsirelik Fakultesi Dergisi). 2017; 33(1):180-190.
- Background: PubMed 25878708Alimohammadi N, Maleki B, Shahriari M, Chitsaz A. Effect of a care plan based on Roy adaptation model biological dimension on stroke patients' physiologic adaptation level. Iran J Nurs Midwifery Res. 2015 Mar-Apr;20(2):275-81.
- BackgroundUzun S. Sister Callista Roy: Adaptation Model. In: Karadag A, Caliskan N, Baykara ZG (eds). Nursing Theories and Models. Istanbul: Akademi Basin ve Yayincilik. 2017: 382-397.
- Background: PubMed 35152900Goudarzi F, Khadivzadeh T, Ebadi A, Babazadeh R. Women's interdependence after hysterectomy: a qualitative study based on Roy adaptation model. BMC Womens Health. 2022 Feb 13;22(1):40. doi: 10.1186/s12905-022-01615-2.
- Background: PubMed 32657901Erol Ursavas F, Karayurt O. Effects of a Roy's Adaptation Model-Guided Support Group Intervention on Sexual Adjustment, Body Image, and Perceived Social Support in Women With Breast Cancer. Cancer Nurs. 2021 Nov-Dec 01;44(6):E382-E394. doi: 10.1097/NCC.0000000000000854.
- BackgroundElibol F, Magden D, Alpar R. Validity and reliability of the parental self-efficacy scale (1-3 years). Bulletin of Community Medicine (Toplum Hekimligi Bulteni). 2007;26(3):25-31.
- BackgroundDilsiz H, Dag I. Feeding Process Maternal Attitude Scale (FPMAS): Development, Validity and Reliability Study. Turk J Pediatr Dis (Turkiye Cocuk Hastaliklari Dergisi). 2020; 14:7-15.
- BackgroundYalaz K, Anlar B, Bayoglu B. Denver II developmental screening test "Turkish standardization". Ankara: Developmental Child Neurology Association. 2010; 11-26.
- Background: PubMed 26777039Neyzi O, Bundak R, Gokcay G, Gunoz H, Furman A, Darendeliler F, Bas F. Reference Values for Weight, Height, Head Circumference, and Body Mass Index in Turkish Children. J Clin Res Pediatr Endocrinol. 2015 Dec;7(4):280-93. doi: 10.4274/jcrpe.2183.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect the privacy of participants and due to ethical committee restrictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Şenay Çetinkaya, Prof. Dr. contact
Şenay Çetinkaya, Prof. Dr. principal investigator
Cukurova University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RAM-based Nursing Empowerment Program and Routine Care and Educational Booklet in people with Congenital Heart Disease and Postoperative Care, run by Cukurova University at 3 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kübra Türker, PhD Student (+905357416538, kubrakadah@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Developmental Screening Test II (Denver II) (time frame: At months 1, 2, 3, 6, 9, and 12 after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07575451, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.