Infertility, FemaleNCT06591637
Fertility Supportive Behavior Education Based On Watson's Theory Of Human Care
A study testing Fertility supportive behavior education based on Watson's Theory of Human Care, Routine nursing care and The booklet "Fertility-Supporting Health Training in people with Infertility, Female and IVF, run by TC Erciyes University at 1 site in Palestinian Territories.
Trial summary
Infertile individuals frequently attempt behavioral changes to enhance the effectiveness of their treatment and improve fertility outcomes. Consequently, this study was designed to assess the impact of fertility supportive behavior education, grounded in Watson's Human Care Theory, on healthy lifestyle behaviors and… Read more about this study
- Who is it for?
- Ages 18 to 32 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female, IVF
- What is being tested?
- Fertility supportive behavior education based on Watson's Theory of Human Care, Routine nursing care and The booklet "Fertility-Supporting Health Training
- Type of treatment
- Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 5 Mar 2023to 30 Sep 2023
- 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 18 to 32 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women have a diagnosis of primary infertility.
- Women over the age of 18 and under the age of 32.
- Women able to read and write in Arabic.
- The cause of infertility must be a male factor.
- Women who are undergoing assisted reproductive techniques, specifically İn Vitro Fertilization-Intracytoplasmatic Sperm Injection.
- Women using the same drugs and protocols for IVF treatment.
- Only women who receive a fresh embryo transfer during their IVF treatment included in the study.
Who cannot join
- Women who have problems with understanding or perception
- The presence of tubal, uterine or other infertility factors in women
- Women undergoing a frozen embryo transfer as part of their IVF treatment
- Women whose pregnancies do not continue or who are diagnosed with a fetal anomaly by the time the healthy lifestyle behaviors scale is re-administered after 3 months excluded from the study.
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
Albasma a private IVF center
Gaza
About this study
Official title: The Effects Of Fertility Supportive Behavior Education Based On Watson's Theory Of Human Care On Healthy Lifestyle Behaviors And İn Vitro Fertilization (IVF) Success İn Women With Primary Infertility
Infertile individuals frequently attempt behavioral changes to enhance the effectiveness of their treatment and improve fertility outcomes. Consequently, this study was designed to assess the impact of fertility supportive behavior education, grounded in Watson's Human Care Theory, on healthy lifestyle behaviors and the success rates of in vitro fertilization (IVF) in women with primary infertility
- Conditions
- Infertility, Female, IVF
- Being tested
- Fertility supportive behavior education based on Watson's Theory of Human Care, Routine nursing care, The booklet "Fertility-Supporting Health Training
- Keywords
- Fertility, Watson's Human Caring Theory, Lifestyle, Nursing Care
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fertility supportive behavior education based on Watson's Theory of Human CareBehavioural
In this study, Watson's Theory of Human Caring guided the development of a care framework and nursing intervention for women with infertility. The researchers adapted the theory and focused on six of the ten carative factors : 1) Adopting values of humanity and devotion; 4) Developing supportive care relationships; 6) Using problem-solving methods for informed decisions; 7) Tailoring teaching to individual needs; 8) Creating a comfortable, peaceful environment; 9) Assisting with basic needs. The nursing care program, integrated with IVF treatments (14-18 days), involved four transpersonal interviews lasting 45-90 minutes each. These interviews were recorded in notes, used to individualize future sessions. The approach included active listening, empathy, and support, with participants encouraged to keep diaries for discussion. Communication was maintained in person, by phone, or email.
Routine nursing careProcedure or surgery
Routine nursing care during IVF treatment includes:
Pre-Treatment Counseling: Providing information and addressing patient questions.
Monitoring and Assessment: Regular checks of health, hormone levels, and ovarian function.
Medication Administration: Giving prescribed fertility drugs and other medications.
Assisting with Procedures: Preparing and assisting with egg retrieval and embryo transfer.
Emotional Support: Offering emotional and psychological support. Education: Instructing on medication use, self-care, and recognizing complications.
Follow-Up Care: Scheduling and managing follow-up appointments to monitor progress
The booklet "Fertility-Supporting Health TrainingDevice
This booklet was prepared in line with the relevant literature and contained educational content aimed at improving healthy lifestyle behaviours . The training booklet included information on the effects of factors such as obesity, weakness, exposure to environmentally harmful substances, smoking and caffeine use on fertility and the methods of coping with these factors. In addition, information on how to use proper nutrition, develop exercise habits and cope with stress was provided. The booklet was distributed to the women at at the onset of the study.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | The intervention group received fertility supportive behavior education based on Watson's Theory of Human Caring and was given a booklet titled 'Fertility-Supporting Health Training' at the onset of treatment. In addition to routine nursing care, the researcher provided detailed intervention and guidance regarding the booklet throughout the treatment period. Receives: Behavioral: Fertility supportive behavior education based on Watson's Theory of Human Care; Procedure: Routine nursing care; Device: The booklet "Fertility-Supporting Health Training |
| control group | Other | The control group received routine nursing care and was given a booklet titled 'Fertility-Supporting Health Training' at the onset of treatment, but the researcher did not provide any additional intervention or guidance regarding the booklet. Receives: Procedure: Routine nursing care; Device: The booklet "Fertility-Supporting Health Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Health-Promoting Lifestyle Profile II instrument
The Health-Promoting Lifestyle Profile II (HPLP-II) is a widely-used instrument for evaluation of health behaviour which has been validated in multiple studies. Based on Pender's Health Promotion Model, it conceptualises an individual's health-promoting lifestyle in terms of the following dimensions; health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations and stress management.
Measured: Both groups completed a Health-Promoting Lifestyle Profile instrument and pre-test measures, at the onset of the study. At the end of treatment after embryo transfer they were administered test measures.After 3 months were administered posttest measure
Secondary outcomes (1)
A quantitative human chorionic gonadotropin (HCG or hCG) blood test
A quantitative human chorionic gonadotropin (HCG or hCG) blood test measures the specific level of HCG in the blood. HCG is a hormone produced in the body during pregnancy.
Results are given in milli-international units per milliliter (mUI/mL).
Normal levels are found in:
Non-pregnant women: less than 5 milli-international units per milliliter Healthy men: less than 2 milli-international units per milliliter
Measured: 14 days after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start5 Mar 2023
- Primary completion15 Aug 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duha Shaqalaih, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591637
- Sponsor's protocol ID
- 1241/23
- Status last verified
- Sep 2024
- First submitted
- 8 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Of Fertility Supportive Behavior Education Based On Watson's Theory Of Human Care On Healthy Lifestyle Behaviors And İn Vitro Fertilization (IVF) Success İn Women With Primary Infertility
- ClinicalTrials.gov ID
- NCT06591637
- Acronym / sponsor ID
- 1241/23
- Conditions
- Infertility, Female, IVF
- Keywords
- Fertility, Watson's Human Caring Theory, Lifestyle, Nursing Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 5 Mar 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 19 Sep 2024 (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.
Infertile individuals frequently attempt behavioral changes to enhance the effectiveness of their treatment and improve fertility outcomes. Consequently, this study was designed to assess the impact of fertility supportive behavior education, grounded in Watson's Human Care Theory, on healthy lifestyle behaviors and the success rates of in vitro fertilization (IVF) in women with primary infertility
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Fertility supportive behavior education based on Watson's Theory of Human Care, Procedure: Routine nursing care, Device: The booklet "Fertility-Supporting Health TrainingThe intervention group received fertility supportive behavior education based on Watson's Theory of Human Caring and was given a booklet titled 'Fertility-Supporting Health Training' at the onset of treatment. In addition to routine nursing care, the researcher provided detailed intervention and guidance regarding the booklet throughout the treatment period. |
| control group | Other | Procedure: Routine nursing care, Device: The booklet "Fertility-Supporting Health TrainingThe control group received routine nursing care and was given a booklet titled 'Fertility-Supporting Health Training' at the onset of treatment, but the researcher did not provide any additional intervention or guidance regarding the booklet. |
Who may qualify
- Ages
- 18 to 32 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women have a diagnosis of primary infertility.
- Women over the age of 18 and under the age of 32.
- Women able to read and write in Arabic.
- The cause of infertility must be a male factor.
- Women who are undergoing assisted reproductive techniques, specifically İn Vitro Fertilization-Intracytoplasmatic Sperm Injection.
Key exclusion criteria (4 listed)
- Women who have problems with understanding or perception
- The presence of tubal, uterine or other infertility factors in women
- Women undergoing a frozen embryo transfer as part of their IVF treatment
- Women whose pregnancies do not continue or who are diagnosed with a fetal anomaly by the time the healthy lifestyle behaviors scale is re-administered after 3 months excluded from the study.
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 |
|---|---|---|
| Fertility supportive behavior education based on Watson's Theory of Human CareIn this study, Watson's Theory of Human Caring guided the development of a care framework and nursing intervention for women with infertility. The researchers adapted the theory and focused on six of the ten carative factors : 1) Adopting values of humanity and devotion; 4) Developing supportive care relationships; 6) Using problem-solving methods for informed decisions; 7) Tailoring teaching to individual needs; 8) Creating a comfortable, peaceful environment; 9) Assisting with basic needs. The nursing care program, integrated with IVF treatments (14-18 days), involved four transpersonal interviews lasting 45-90 minutes each. These interviews were recorded in notes, used to individualize future sessions. The approach included active listening, empathy, and support, with participants encouraged to keep diaries for discussion. Communication was maintained in person, by phone, or email. | Behavioural | intervention group |
| Routine nursing careRoutine nursing care during IVF treatment includes: Pre-Treatment Counseling: Providing information and addressing patient questions. Monitoring and Assessment: Regular checks of health, hormone levels, and ovarian function. Medication Administration: Giving prescribed fertility drugs and other medications. Assisting with Procedures: Preparing and assisting with egg retrieval and embryo transfer. Emotional Support: Offering emotional and psychological support. Education: Instructing on medication use, self-care, and recognizing complications. Follow-Up Care: Scheduling and managing follow-up appointments to monitor progress | Procedure or surgery | control group, intervention group |
| The booklet "Fertility-Supporting Health TrainingThis booklet was prepared in line with the relevant literature and contained educational content aimed at improving healthy lifestyle behaviours . The training booklet included information on the effects of factors such as obesity, weakness, exposure to environmentally harmful substances, smoking and caffeine use on fertility and the methods of coping with these factors. In addition, information on how to use proper nutrition, develop exercise habits and cope with stress was provided. The booklet was distributed to the women at at the onset of the study. | Device | control group, intervention group |
Primary outcome
The Health-Promoting Lifestyle Profile II instrument
Time frame: Both groups completed a Health-Promoting Lifestyle Profile instrument and pre-test measures, at the onset of the study. At the end of treatment after embryo transfer they were administered test measures.After 3 months were administered posttest measure
The Health-Promoting Lifestyle Profile II (HPLP-II) is a widely-used instrument for evaluation of health behaviour which has been validated in multiple studies. Based on Pender's Health Promotion Model, it conceptualises an individual's health-promoting lifestyle in terms of the following dimensions; health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations and stress management.
1 secondary outcome
A quantitative human chorionic gonadotropin (HCG or hCG) blood test
Time frame: 14 days after embryo transfer
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 19 Sep 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fertility supportive behavior education based on Watson's Theory of Human Care, Routine nursing care and The booklet "Fertility-Supporting Health Training in people with Infertility, Female and IVF, run by TC Erciyes University at 1 site in Palestinian Territories.
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 7 inclusion and 4 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 19 Sep 2024. 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 Palestinian Territories. 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?
The Health-Promoting Lifestyle Profile II instrument (time frame: Both groups completed a Health-Promoting Lifestyle Profile instrument and pre-test measures, at the onset of the study. At the end of treatment after embryo transfer they were administered test measures.After 3 months were administered posttest measure). 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 19 Sep 2024.