Postpartum PeriodNCT04783324
The Effect of the E-Mobile Health Application on Postpartum Adaptation
A study testing E-Mobile Health Application in people with Postpartum Period and Pregnant Women, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this research is to determine the effect of the e-mobile health application on postpartum adaptation. The study will consist of two groups: Experimental group and control group. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Period, Pregnant Women, Adaptation
- What is being tested?
- E-Mobile Health Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Mar 2021to 29 Aug 2021
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primiparous
- Being in the 32nd week of pregnancy and above
- Not getting any diagnosis that poses a risk for pregnancy (Multiple pregnancy, Gestational Diabetes, Preeclampsia, Eclampsia, Placenta Previa, Fetal Anomaly, Intrauterine Growth Retardation)
- Speaking Turkish
- To be at least a primary school graduate
- Having a smart phone with Android operating system
Who cannot join
- Multiparous
- Being under 32 weeks of pregnancy
- Getting any diagnosis that poses a risk to pregnancy (Multiple pregnancy, Gestational Diabetes, Preeclampsia, Eclampsia, Placenta Previa, Fetal Anomaly, Intrauterine Growth Retardation)
- Not speaking Turkish
- Having a smartphone with an operating system other than Android
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the E-Mobile Health Application for Pregnant Women Created Based on the Roy's Adaptation Model on Postpartum Adaptation
The purpose of this research is to determine the effect of the e-mobile health application on postpartum adaptation. The study will consist of two groups: Experimental group and control group.
Read the detailed description
This is a randomized controlled trial. A questionnaire and The Postpartum Self-Evaluation Questionnaire will be used to collect data. The main hypothesis of the research: Postpartum Self-Evaluation Questionnaire total mean score of women who use e-mobile health application created according to Roy's Adaptation Model is not different from the total mean score of women in the control group.
Research sample will consist of a total of 62 pregnant women, 31 in the experimental group and 31 in the control group. The data will be evaluated with the SPSS (Statistical Package of SocialSciences) 24.0 package program.
- Conditions
- Postpartum Period, Pregnant Women, Adaptation, Mobile Applications
- Being tested
- E-Mobile Health Application
- Keywords
- Mobile Applications, Postpartum Period, Adaptation, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-Mobile Health ApplicationBehavioural
The e-mobile health application prepared by the researcher will be used. E-mobile health application include information about postpartum care.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Pregnant women in the intervention group will use the e-mobile health application developed by the researcher. Receives: Behavioral: E-Mobile Health Application |
| Control Group | No intervention | Pregnant women in the control group will not be intervened and standard care will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum Adaptation
Postpartum adaptation according to Postpartum Self Evaluation Scale. Postpartum self evaluation questionnaire consists of 82 questions in total. The questions are scored between 1 and 4 points. The minimum value that can be obtained from the scale is 82, the maximum value is 328. It is seen that the lower the score in this scale, the higher the postpartum adaptaion of the individual.
Measured: At postpartum tenth day (baseline) and last-interview at postpartum sixth week (change from baseline at sixth week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start25 Mar 2021
- Primary completion29 Aug 2021
- Study completion29 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum PeriodStudies of the same condition, open and under way.
- More trials run by Gazi 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
- The study consists of two groups: Experimental group and control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sultan Ozkan, Gazi University
- Investigators
- Şengül Yaman Sözbir, PhD, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783324
- Sponsor's protocol ID
- SultanOzkan
- Status last verified
- Oct 2021
- First submitted
- 22 Jan 2021
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozkan Sat S, Yaman Sozbir S. Randomized Controlled Trial of a Mobile Health Application Based on Roy's Adaptation Model on Postpartum Adaptation. Nurs Res. 2023 May-Jun 01;72(3):E16-E24. doi: 10.1097/NNR.0000000000000647. Epub 2023 Feb 21.
PubMed 36920158
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the E-Mobile Health Application for Pregnant Women Created Based on the Roy's Adaptation Model on Postpartum Adaptation
- ClinicalTrials.gov ID
- NCT04783324
- Acronym / sponsor ID
- SultanOzkan
- Conditions
- Postpartum Period, Pregnant Women, Adaptation, Mobile Applications
- Keywords
- Mobile Applications, Postpartum Period, Adaptation, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 29 Aug 2021 (actual)
- Study completion
- 29 Aug 2021 (actual)
- First posted
- 5 Mar 2021 (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 research is to determine the effect of the e-mobile health application on postpartum adaptation. The study will consist of two groups: Experimental group and control group.
Detailed description
This is a randomized controlled trial. A questionnaire and The Postpartum Self-Evaluation Questionnaire will be used to collect data. The main hypothesis of the research: Postpartum Self-Evaluation Questionnaire total mean score of women who use e-mobile health application created according to Roy's Adaptation Model is not different from the total mean score of women in the control group.
Research sample will consist of a total of 62 pregnant women, 31 in the experimental group and 31 in the control group. The data will be evaluated with the SPSS (Statistical Package of SocialSciences) 24.0 package program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study consists of two groups: Experimental group and control group.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: E-Mobile Health ApplicationPregnant women in the intervention group will use the e-mobile health application developed by the researcher. |
| Control Group | No intervention | –Pregnant women in the control group will not be intervened and standard care will be applied. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Primiparous
- Being in the 32nd week of pregnancy and above
- Not getting any diagnosis that poses a risk for pregnancy (Multiple pregnancy, Gestational Diabetes, Preeclampsia, Eclampsia, Placenta Previa, Fetal Anomaly, Intrauterine Growth Retardation)
- Speaking Turkish
- To be at least a primary school graduate
Key exclusion criteria (5 listed)
- Multiparous
- Being under 32 weeks of pregnancy
- Getting any diagnosis that poses a risk to pregnancy (Multiple pregnancy, Gestational Diabetes, Preeclampsia, Eclampsia, Placenta Previa, Fetal Anomaly, Intrauterine Growth Retardation)
- Not speaking Turkish
- Having a smartphone with an operating system other than Android
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 |
|---|---|---|
| E-Mobile Health ApplicationThe e-mobile health application prepared by the researcher will be used. E-mobile health application include information about postpartum care. | Behavioural | Experimental Group |
Primary outcome
Postpartum Adaptation
Time frame: At postpartum tenth day (baseline) and last-interview at postpartum sixth week (change from baseline at sixth week)
Postpartum adaptation according to Postpartum Self Evaluation Scale. Postpartum self evaluation questionnaire consists of 82 questions in total. The questions are scored between 1 and 4 points. The minimum value that can be obtained from the scale is 82, the maximum value is 328. It is seen that the lower the score in this scale, the higher the postpartum adaptaion of the individual.
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 5 Nov 2021.
- Derived from this study: PubMed 36920158Ozkan Sat S, Yaman Sozbir S. Randomized Controlled Trial of a Mobile Health Application Based on Roy's Adaptation Model on Postpartum Adaptation. Nurs Res. 2023 May-Jun 01;72(3):E16-E24. doi: 10.1097/NNR.0000000000000647. Epub 2023 Feb 21.
- 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.
Şengül Yaman Sözbir, PhD principal investigator
Gazi 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 E-Mobile Health Application in people with Postpartum Period and Pregnant Women, run by Gazi 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 6 inclusion and 5 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 5 Nov 2021. 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?
Postpartum Adaptation (time frame: At postpartum tenth day (baseline) and last-interview at postpartum sixth week (change from baseline at sixth week)). 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 NCT04783324, which also lists 1 linked publication.
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 5 Nov 2021.