Stem Cell TransplantationNCT05438823
Technology Supported Education Program Based on Human Care Theory
A study testing Educational Programe in people with Stem Cell Transplantation and Nursing Caries, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Hematopoietic stem cell transplantation is applied in the childhood age group for many reasons such as hematological malignancies, immune deficiencies, hemoglobinopathies, bone marrow failures and congenital metabolic diseases. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stem Cell Transplantation, Nursing Caries
- What is being tested?
- Educational Programe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Feb 2024to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Primary care parent of the child (0-18 years old) after HSCT
- Having mobile internet access
- Discharge planned
Who cannot join
- Parent's failure to attend at least 3 sessions of the training program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Technology Supported Education Program Based on Human Care Theory on Knowledge, Self-Efficacy, Quality of Life and Anxiety of Parents of Children With Stem Cell Transplantation
Hematopoietic stem cell transplantation is applied in the childhood age group for many reasons such as hematological malignancies, immune deficiencies, hemoglobinopathies, bone marrow failures and congenital metabolic diseases. The transplantation process, which requires a long hospitalization process, is an experience that causes anxiety for the child and the caregiver.
Read the detailed description
It is known that during the home care process after discharge, parents experience anxiety because they are away from health professionals, and they need information and support in their care needs. This research has two purposes. 1; Developing a technology-supported home care education program (IBK-EBP) (supported by face-to-face education and mobile application) based on Human Theory of Care (IBK) for home care of children with hematopoietic stem cell transplantation. 2; It is to determine the effect of IBK-EBP education program on parents' knowledge, self-efficacy, anxiety level and quality of life. The study was planned in a single-center, follow-up, double-blind, randomized controlled design. The research sample was planned to be composed of 40 parents, 20 of which were interventions and 20 of which were controls. The home care training program, which will be prepared with up-to-date information in line with the literature; It includes face-to-face training sessions and ensuring the continuity of education at home with the mobile application to be developed. The content of the home care training program to be prepared in this context; regulation of the home environment, compliance with treatment, food safety, personal hygiene and care, social environment, planning of school life and progressive relaxation exercises. As part of the training program, parents will be shown a CD of progressive relaxation exercises before the training. Research data will be collected by a nurse other than the researchers, who was not involved in the study. Research data will be collected using the "Parent and Child Identification Form", "Parent's Knowledge Level of Care Assessment Form", "General Self-Efficacy Scale", "Quality of Life Scale for Caregivers of Cancer Patients" and "Spielberger State and Trait Anxiety Inventory". With a technology-supported home care education program to be developed based on the Human Care Theory it is predicted that the knowledge, self-efficacy, quality of life of the parents will increase and the level of anxiety will decrease, by ensuring the ease and continuity of access to information.
- Conditions
- Stem Cell Transplantation, Nursing Caries
- Being tested
- Educational Programe
- Keywords
- caregiver, parent, stem cell transplantation, self-efficacy, quality of life, theory of human caring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational ProgrameOther
IBK-EBP will be administered to parents in six sessions in six days. After six days of training, the mobile application will be used by parents for 8 weeks. The frequency of use of the mobile application will be left entirely to the needs of the parents and reminders will be made through the mobile application. In addition, the video used during the face-to-face training, progressive relaxation exercise videos and motivational sentences will also be included in the mobile application.
| Study group | Role | What they receive |
|---|---|---|
| İntervention group | Experimental | The sample of the study will be the parents of children who have had hematopoietic stem cell transplantation at Akdeniz University Hospital and whose discharge is planned (n=20). Receives: Other: Educational Programe |
| Control group | No intervention | The control group will be the parents of children who underwent hematopoietic stem cell transplantation at Akdeniz University Hospital and are planned to be discharged (n=20). Participants in this group will receive routine care, and at the end of the study, training program will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge
There are 13 questions in the questionnaire prepared in line with the literature. The questions will be answered as "strongly agree", "agree", "undecided", "disagree", "strongly disagree".
Measured: 1 year
Self-Efficacy
Generalized Self-Efficacy Scale, developed by Schwarzer and Jarusalem (1995) and validated in Turkish by Aypay (2010), consists of 10 items in total. The response category is a 4-point scale and is scored as "Totally wrong = 1 point", "Slightly correct = 2 points", "Moderately correct = 3 points", "Totally correct = 4 points". There is no inverse item and cut-off point in the scale. The lowest 10 and the highest 40 points are taken from the scale. It is interpreted as "perceived self-efficacy increases as the scale score increases".
Measured: 1 year
Quality Life
The Caregiver Quality of Life Index Cancer Scale (CQOLC), developed by Weitzner et al. (1999), aims to measure caregivers' quality of life, including their physical, emotional, familial and social functions. The total score of each sub-dimension and scale in the scale ranges from 0 to 140. In the scale, financial distress, discomfort sub-dimensions and some questions consist of reversed statements. The scale contains a total of 35 items.
Measured: 1 year
Anxiety
It consists of 2 subscales, namely state and trait anxiety. State Anxiety Sub-Scale (STAI-S), an individual's at a certain time and under certain conditions; The Trait Anxiety Subscale (STAI-T) usually requires a description of how one feels. The inventory is answered via 4-point scales. The emotions and behaviors expressed in the items of the State Anxiety Sub-Scale are indicated by choosing one of the options "(1) Not at all, (2) A little, (3) A lot and (4) Completely" according to the severity of such experiences. Emotions and behaviors expressed in Trait Anxiety Sub-Scale items are according to their frequency levels; It is marked as (1) Almost Never, (2) Sometimes, (3) Often, and (4) Almost Always.
Measured: 1 hyear
Secondary outcomes (1)
Patient Satisfaction Evaluation Form According to Watson Improvement Processes
Watson is a form developed by Watson et al. (2010) to evaluate IBC-based nursing care. This satisfaction form is not a scale. The form consists of six questions in total. The first five questions are scored between 1 and 7, and are evaluated as never (1) and always (7). The sixth question is in the form of an open-ended question in which the "moments of care" in the given nursing care are evaluated.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start3 Feb 2024
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem Cell TransplantationStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Institutes of Turkey
- Responsible party
- Principal investigator, Duygu ALTUNTAŞ, Akdeniz University
- Investigators
- Emine EFE, Proff.Dr., Principal investigator, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438823
- Sponsor's protocol ID
- Akdenizuni
- Status last verified
- Feb 2024
- First submitted
- 26 Jun 2022
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Technology Supported Education Program Based on Human Care Theory on Knowledge, Self-Efficacy, Quality of Life and Anxiety of Parents of Children With Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT05438823
- Acronym / sponsor ID
- Akdenizuni
- Conditions
- Stem Cell Transplantation, Nursing Caries
- Keywords
- caregiver, parent, stem cell transplantation, self-efficacy, quality of life, theory of human caring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Collaborators
- Health Institutes of Turkey
- Study start
- 3 Feb 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 30 Jun 2022 (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.
Hematopoietic stem cell transplantation is applied in the childhood age group for many reasons such as hematological malignancies, immune deficiencies, hemoglobinopathies, bone marrow failures and congenital metabolic diseases. The transplantation process, which requires a long hospitalization process, is an experience that causes anxiety for the child and the caregiver.
Detailed description
It is known that during the home care process after discharge, parents experience anxiety because they are away from health professionals, and they need information and support in their care needs. This research has two purposes. 1; Developing a technology-supported home care education program (IBK-EBP) (supported by face-to-face education and mobile application) based on Human Theory of Care (IBK) for home care of children with hematopoietic stem cell transplantation. 2; It is to determine the effect of IBK-EBP education program on parents' knowledge, self-efficacy, anxiety level and quality of life. The study was planned in a single-center, follow-up, double-blind, randomized controlled design. The research sample was planned to be composed of 40 parents, 20 of which were interventions and 20 of which were controls. The home care training program, which will be prepared with up-to-date information in line with the literature; It includes face-to-face training sessions and ensuring the continuity of education at home with the mobile application to be developed. The content of the home care training program to be prepared in this context; regulation of the home environment, compliance with treatment, food safety, personal hygiene and care, social environment, planning of school life and progressive relaxation exercises. As part of the training program, parents will be shown a CD of progressive relaxation exercises before the training. Research data will be collected by a nurse other than the researchers, who was not involved in the study. Research data will be collected using the "Parent and Child Identification Form", "Parent's Knowledge Level of Care Assessment Form", "General Self-Efficacy Scale", "Quality of Life Scale for Caregivers of Cancer Patients" and "Spielberger State and Trait Anxiety Inventory". With a technology-supported home care education program to be developed based on the Human Care Theory it is predicted that the knowledge, self-efficacy, quality of life of the parents will increase and the level of anxiety will decrease, by ensuring the ease and continuity of access to information.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| İntervention group | Experimental | Other: Educational ProgrameThe sample of the study will be the parents of children who have had hematopoietic stem cell transplantation at Akdeniz University Hospital and whose discharge is planned (n=20). |
| Control group | No intervention | –The control group will be the parents of children who underwent hematopoietic stem cell transplantation at Akdeniz University Hospital and are planned to be discharged (n=20). Participants in this group will receive routine care, and at the end of the study, training program will be applied. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Primary care parent of the child (0-18 years old) after HSCT
- Having mobile internet access
- Discharge planned
Key exclusion criteria (1 listed)
- Parent's failure to attend at least 3 sessions of the training program
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 |
|---|---|---|
| Educational ProgrameIBK-EBP will be administered to parents in six sessions in six days. After six days of training, the mobile application will be used by parents for 8 weeks. The frequency of use of the mobile application will be left entirely to the needs of the parents and reminders will be made through the mobile application. In addition, the video used during the face-to-face training, progressive relaxation exercise videos and motivational sentences will also be included in the mobile application. | Other | İntervention group |
Primary outcome
Knowledge
Time frame: 1 year
There are 13 questions in the questionnaire prepared in line with the literature. The questions will be answered as "strongly agree", "agree", "undecided", "disagree", "strongly disagree".
Self-Efficacy
Time frame: 1 year
Generalized Self-Efficacy Scale, developed by Schwarzer and Jarusalem (1995) and validated in Turkish by Aypay (2010), consists of 10 items in total. The response category is a 4-point scale and is scored as "Totally wrong = 1 point", "Slightly correct = 2 points", "Moderately correct = 3 points", "Totally correct = 4 points". There is no inverse item and cut-off point in the scale. The lowest 10 and the highest 40 points are taken from the scale. It is interpreted as "perceived self-efficacy increases as the scale score increases".
Quality Life
Time frame: 1 year
The Caregiver Quality of Life Index Cancer Scale (CQOLC), developed by Weitzner et al. (1999), aims to measure caregivers' quality of life, including their physical, emotional, familial and social functions. The total score of each sub-dimension and scale in the scale ranges from 0 to 140. In the scale, financial distress, discomfort sub-dimensions and some questions consist of reversed statements. The scale contains a total of 35 items.
Anxiety
Time frame: 1 hyear
It consists of 2 subscales, namely state and trait anxiety. State Anxiety Sub-Scale (STAI-S), an individual's at a certain time and under certain conditions; The Trait Anxiety Subscale (STAI-T) usually requires a description of how one feels. The inventory is answered via 4-point scales. The emotions and behaviors expressed in the items of the State Anxiety Sub-Scale are indicated by choosing one of the options "(1) Not at all, (2) A little, (3) A lot and (4) Completely" according to the severity of such experiences. Emotions and behaviors expressed in Trait Anxiety Sub-Scale items are according to their frequency levels; It is marked as (1) Almost Never, (2) Sometimes, (3) Often, and (4) Almost Always.
1 secondary outcome
Patient Satisfaction Evaluation Form According to Watson Improvement Processes
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Emine EFE, Proff.Dr. principal investigator
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Programe in people with Stem Cell Transplantation and Nursing Caries, run by Akdeniz University at 1 site 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 3 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: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2025.