Nurse's RoleNCT04109651
The Effect of Nursing Interventions on Maternal Attachment, Parental Self-efficacy and Infant Development
A study testing Nursing intervention in people with Nurse's Role and Parenting, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine the effects of Meleis 'Transition Theory based health improvement monitoring program on infants' development, maternal attachment and parental self-efficacy in 36-40 weeks of gestation and in the first and fourth months after birth. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nurse's Role, Parenting, Self Efficacy
- What is being tested?
- Nursing intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Oct 2018to 12 Aug 2019
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having at least primary school graduation
- 18 Years and older
- Lack of any chronic disease
Who cannot join
- Multiple pregnancy
- Risk of preterm birth
- Does not speak Turkish
- Pregnant / mothers not attending at least one education and / or measurement
- Want to leave the work
- Presence of mental or physical illnesses such as postpartum depression during follow-up
- Baby; Presence of congenital and / or metabolic disease during prenatal and postnatal postnatal follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Nursing Intervention on Mother and Infant, Materna Attachment, Parental Self-efficacy, Infant Development
The aim of this study was to determine the effects of Meleis 'Transition Theory based health improvement monitoring program on infants' development, maternal attachment and parental self-efficacy in 36-40 weeks of gestation and in the first and fourth months after birth. Sample was 64 (experimental group:32; control group: 32), alfa=0,05 and power=0.80 at the end of study. The experimental group received nursing interventions based on Meleis' Transition Theory, while the control group received routine primary health care. Data were collected 3 times: pretest, 3 and 7 months after intervention (for experimental group) and 3 and 7 months after pretest (for control group).
Read the detailed description
Motherhood is one of the most important milestones in a woman's life, and at the same time the beginning of a process in which very important responsibilities are undertaken. The mother needs knowledge, skills and energy to fulfill her new responsibilities. The development of motherhood identity is the process of learning motherhood behaviors of women. This process starts with the recognition of pregnancy, develops during pregnancy and continues after birth. Transition Theory is a suitable tool for nurses to understand the transition to parenting, a developmental type of transition. Appropriate nursing interventions tailored to the needs of pregnant women and women who have just given birth are needed. Targeted / predicted change in the large / large effect size of the mothers in the experimental group (effect size 0.80, 80% of the standard deviation) with the Health Promotion Monitoring Program, the sample calculation with 5% alpha error and 80% power was the minimum for each group. It was determined that a total of 52 people (26 *) should be recruited (G * Power 3.1.9.2). It was decided to include at least 32 people in each working group with a 20% surplus, considering that they might be lost in data collection. Women's experiences in transition to motherhood should be sought to propose, define, and explain professional interventions. In this study, a Health Promotion Program starting from 36-40 weeks of gestation until the sixth month of birth was administered to the mothers registered at the primary health care center in Karatay, Konya. In this study, the investigator planned to increase maternal infant attachment, to increase parental self-efficacy, to keep infant development at the best level, thus ensuring a healthy transition for the mother.
Duration of intervention and collecting data for the study was 11 months. Data was collected using information form (21 item; information about participant, parents and infant), three scales (Turkish Version of Maternal Attachment Inventory; parental self-efficacy scale, Denver II development screening test). Scales validation and reliability studies were made for Turkish population.
- Conditions
- Nurse's Role, Parenting, Self Efficacy, Development, Child, Attachment
- Being tested
- Nursing intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing interventionOther
Also called No Intervention: Control Group
Nursing Intervention: This intervention was planned based on Meleis' Transition Theory. So it includes individual counseling and training.
In the Health Promotion Monitoring Program; three training modules and one reminder module were implemented and telephone counseling was provided. Various training tools were used in these trainings. Three different power point presentations were made during the training sessions. Illustrated printed training material was used. At the end of the training, training booklet was given to the participants.
| Study group | Role | What they receive |
|---|---|---|
| Nursing İntervention | Experimental | Intervention: Other: Nursing intervention Receives: Other: Nursing intervention |
| No Intervention: Control Group | Other | Receive routine nursing care Receives: Other: Nursing intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
infant development level
infant development at a high level
Measured: At the end of 7 month
Secondary outcomes (2)
Maternal attachment scores
Mother will increase infant attachment level
Measured: At the end of 7 month
Parental self-efficacy scales scores
Mother self-efficacy level will increase
Measured: At the end of 7 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start3 Oct 2018
- Primary completion12 Aug 2019
- Study completion12 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies 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
- Model description
- Interventional (Clinical Trial)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Figen Türkdüdükçü, KTO Karatay University
- Investigators
- FATMA TAŞ ARSLAN, Study director, SELÇUK UNİVERSİTY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109651
- Sponsor's protocol ID
- KaratayU
- Status last verified
- Sep 2019
- First submitted
- 25 Sep 2019
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not plan to share any data of participants.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Nursing Intervention on Mother and Infant, Materna Attachment, Parental Self-efficacy, Infant Development
- ClinicalTrials.gov ID
- NCT04109651
- Acronym / sponsor ID
- KaratayU
- Conditions
- Nurse's Role, Parenting, Self Efficacy, Development, Child, Attachment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 3 Oct 2018 (actual)
- Primary completion
- 12 Aug 2019 (actual)
- Study completion
- 12 Aug 2019 (actual)
- First posted
- 30 Sep 2019 (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 aim of this study was to determine the effects of Meleis 'Transition Theory based health improvement monitoring program on infants' development, maternal attachment and parental self-efficacy in 36-40 weeks of gestation and in the first and fourth months after birth. Sample was 64 (experimental group:32; control group: 32), alfa=0,05 and power=0.80 at the end of study. The experimental group received nursing interventions based on Meleis' Transition Theory, while the control group received routine primary health care. Data were collected 3 times: pretest, 3 and 7 months after intervention (for experimental group) and 3 and 7 months after pretest (for control group).
Detailed description
Motherhood is one of the most important milestones in a woman's life, and at the same time the beginning of a process in which very important responsibilities are undertaken. The mother needs knowledge, skills and energy to fulfill her new responsibilities. The development of motherhood identity is the process of learning motherhood behaviors of women. This process starts with the recognition of pregnancy, develops during pregnancy and continues after birth. Transition Theory is a suitable tool for nurses to understand the transition to parenting, a developmental type of transition. Appropriate nursing interventions tailored to the needs of pregnant women and women who have just given birth are needed. Targeted / predicted change in the large / large effect size of the mothers in the experimental group (effect size 0.80, 80% of the standard deviation) with the Health Promotion Monitoring Program, the sample calculation with 5% alpha error and 80% power was the minimum for each group. It was determined that a total of 52 people (26 *) should be recruited (G * Power 3.1.9.2). It was decided to include at least 32 people in each working group with a 20% surplus, considering that they might be lost in data collection. Women's experiences in transition to motherhood should be sought to propose, define, and explain professional interventions. In this study, a Health Promotion Program starting from 36-40 weeks of gestation until the sixth month of birth was administered to the mothers registered at the primary health care center in Karatay, Konya. In this study, the investigator planned to increase maternal infant attachment, to increase parental self-efficacy, to keep infant development at the best level, thus ensuring a healthy transition for the mother.
Duration of intervention and collecting data for the study was 11 months. Data was collected using information form (21 item; information about participant, parents and infant), three scales (Turkish Version of Maternal Attachment Inventory; parental self-efficacy scale, Denver II development screening test). Scales validation and reliability studies were made for Turkish population.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Interventional (Clinical Trial)
| Arm | Type | Receives |
|---|---|---|
| Nursing İntervention | Experimental | Other: Nursing interventionIntervention: Other: Nursing intervention |
| No Intervention: Control Group | Other | Other: Nursing interventionReceive routine nursing care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having at least primary school graduation
- 18 Years and older
- Lack of any chronic disease
Key exclusion criteria (7 listed)
- Multiple pregnancy
- Risk of preterm birth
- Does not speak Turkish
- Pregnant / mothers not attending at least one education and / or measurement
- Want to leave the work
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 |
|---|---|---|
| Nursing interventionAlso: No Intervention: Control GroupNursing Intervention: This intervention was planned based on Meleis' Transition Theory. So it includes individual counseling and training. In the Health Promotion Monitoring Program; three training modules and one reminder module were implemented and telephone counseling was provided. Various training tools were used in these trainings. Three different power point presentations were made during the training sessions. Illustrated printed training material was used. At the end of the training, training booklet was given to the participants. | Other | No Intervention: Control Group, Nursing İntervention |
Primary outcome
infant development level
Time frame: At the end of 7 month
infant development at a high level
2 secondary outcomes
Maternal attachment scores
Time frame: At the end of 7 month
Parental self-efficacy scales scores
Time frame: At the end of 7 month
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 30 Sep 2019.
- Individual participant dataSharing planned: No. I do not plan to share any data of participants.
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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.
FATMA TAŞ ARSLAN study director
SELÇUK UNİVERSİTY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing intervention in people with Nurse's Role and Parenting, run by KTO Karatay 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 7 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 30 Sep 2019. 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?
infant development level (time frame: At the end of 7 month). 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 30 Sep 2019.