Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000225314
Ethics application status
Approved
Date submitted
16/11/2016
Date registered
10/02/2017
Date last updated
10/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of prenatal education based on the Roy Adaptation Model on gestational hypertension, adaptation to pregnancy and pregnancy outcomes: a randomized controlled trial
Scientific title
To analyze the impact of prenatal education based on the Roy Adaptation Model on gestational hypertension, adaptation to pregnancy and on maternal and neonatal outcomes in gestational hypertension-pregnant women aged between 18 to 35..
Secondary ID [1] 290562 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gestational hypertension 301005 0
Condition category
Condition code
Cardiovascular 300802 300802 0 0
Hypertension
Reproductive Health and Childbirth 301330 301330 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A quasi-experimental, randomised controlled trial
Individual one-on-one meeting was used in all educations. Educations were given by a researcher (expert nurse) into an appropriate room for hospital. A Pregnancy Educational Booklet on Gestational Hypertension designed according to RAM was used in all education.
RAM was used in the implementation of the study. According to this model, individuals are systems that adapt themselves by interacting with constantly changing environmental stimuli. RAM distinguishes the environmental stimuli that impact the individual under three headings. Focal stimuli are stimuli that the individual is in immediate contact with, contextual stimuli are other stimuli that have positive or negative effects on the focal stimuli, and residual stimuli, which always have an effect on the individual but consist of internal or external factors that cannot fully be explained. The individual uses these stimuli as coping mechanisms and responds to them with his/her behavior. Four domains of adaptation have been defined in order to assess behavior in the model. In the physiologic domain, adaptation involves maintaining the physical integrity of the system. The self-concept domain is related to basic needs that are needed to maintain psychological integrity, such as body image and self-concept. The role function domain consists of the roles that are needed to maintain social integrity, such as being a mother or father. The interdependence domain involves developing and maintaining relationships with individuals and nurturing these relationships with social support.
RAM classifies behavioral responses in these modes of adaptation as adaptive or non-adaptive. Nursing diagnoses are defined after non-adaptive behavior is determined and then interventions are planned accordingly. Here, the nursing intervention is the education provided that addresses the non-adaptive behavior in the four domains of adaptation. The nurse then makes another assessment to track the effects of the intervention. If the individual develops an adaptive behavior, the nursing intervention has been effective; if non-adaptive behavior has developed, the intervention is considered to have been ineffective.
This study is based on RAM's four modes of adaptation. The material prepared for the education related to the (1) physiologic domain included information on the development of pregnancy, the physiological changes occurring during pregnancy, hypertensive illnesses, daily life activities and the effects of gestational hypertension on pregnancy. (2) Related to the self-concept domain, the material included the effects of pregnancy and gestational hypertension on self-concept (body image and thoughts about how to cope with gestational hypertension). (3) With regard to the role function domain, the material included the effects of pregnancy and gestational hypertension on the role functions of the pregnant woman. (4) In the interdependence domain, the materials were focused on the importance of significant people and support systems in the pregnant women's life in terms of the pregnancy and gestational hypertension.
The educational booklet was prepared in a manner that encompassed the four modes of adaptation described in RAM. The first section of the educational booklet dealt with the physiologic mode, containing information on the start of pregnancy, the physiological changes taking place in the pregnant women, hypertensive illnesses, activities of daily life and the effect of gestational hypertension on pregnancy. In the second section, which dealt with self-concept, the impact of pregnancy and gestational hypertension on self-concept was discussed. In the third section covering the role function mode, the material included the effects of pregnancy and gestational hypertension on the role functions of the pregnant woman. Lastly, in the section on the interdependence mode, the material was focused on the importance of significant people and support systems in the pregnant woman's life in terms of the pregnancy and gestational hypertension.
Educational sessions were held with the pregnant women in the education group five times in their Weeks 20-24 of their pregnancy, once in their 30th-34th weeks, a total of six times.
in their Weeks 20-24 of their pregnancy which individual coaching was provided on how to cope with the stimuli causing the non-adaptive behavior that had been previously determined by means of the Educational Booklet. Although the goal in this model-based education was to diminish or eliminate the impact of the stimuli that caused the non-adaptive behavior, if behaviors or stimuli could not be changed, developing a positive perception became the objective. At the educational sessions, five sessions were held--two sessions to cover the physiologic mode, and one session each for the other modes of adaptation (self-concept, role functions and interdependence). The sessions each took approximately 20-40 minutes. Additionally, behavior changes proposed to be achieved until the next visit that would improve the pregnant women's adaptation to pregnancy and to illness during pregnancy were planned and an Education Booklet was given to the women.
in their 30th-34th weeks of their pregnancy which education was provided by means of the Education Booklet on areas of adaptation where problems were experienced, after which planning was carried out for the next meeting to facilitate behavior changes that could improve adaptation to pregnancy and prenatal illnesses. This educational session took approximately 30-40 minutes.
Log of session was used to monitor adherence to the intervention.
Intervention code [1] 296426 0
Behaviour
Intervention code [2] 297049 0
Treatment: Other
Comparator / control treatment
The meetings with the pregnant women in the control group were held in Weeks 20-24 and 30-34 of the pregnancy and on the first and second days after the birth. At the first meeting the pregnant women were invited into a suitable room and, using the face-to-face interviewing method, the Informed Consent Form, the Identifying Characteristics Form and the PSEQ-AP were filled out, after which the women were given routine care. In addition, the pregnant women were asked to have their blood pressure measured and recorded once a week over the period of the study. At the second meeting, the researcher filled out the PSEQ--AP and Gestational Hypertension Prognosis Form. At the third meeting, the Gestational Hypertension Prognosis and the Maternal and Neonatal Outcomes Evaluation Forms were administered.
Control group
Active

Outcomes
Primary outcome [1] 300223 0
Gestational hypertension, assessed using sphygmomanometer (for systolic and diastolic blood pressure measurement)
Timepoint [1] 300223 0
30th-34th weeks gestational and on the first and second days after the birth
Primary outcome [2] 300224 0
Gestational hypertension, assessed using laboratory test proteinuria in urine
Timepoint [2] 300224 0
30th-34th weeks gestational and on the first and second days after the birth
Primary outcome [3] 300792 0
Acceptance of pregnancy assessed using Prenatal Self-reporting Scale-Acceptance of Pregnancy Subscale
Timepoint [3] 300792 0
30th-34th weeks gestational
Secondary outcome [1] 329428 0
Presentation position disorder, congenital malformation, RDS, neonatal hypoglycemia, neonatal hyperbilirubinemia, infant taken into intensive care assessed by review of medical records. This a composite secondary outcome.
Timepoint [1] 329428 0
on the first and second days after the birth
Secondary outcome [2] 329931 0
Infant's head circumference, infant's length, Infant's weight,infant's stay at hospital, mother's stay at hospital destational week assessed by review of medical records. This a composite secondary outcome.
Timepoint [2] 329931 0
on the first and second days after the birth
Secondary outcome [3] 329932 0
First-minute Apgar score and Fifth-minute Apgar score assessed by review of medical records
Timepoint [3] 329932 0
on the first and second days after the birth

Eligibility
Key inclusion criteria
20th-24th gestational weeks, received a diagnosis of hypertension and taking antihypertensives.
Minimum age
18 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
past 24th gestational week, under the age of 18 and over the age of 35, illiterate, more than four pregnancies, body mass index of below 19 and over 30, and did not consent to participate in the study

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/10/2013
Date of last participant enrolment
Anticipated
Actual
11/08/2015
Date of last data collection
Anticipated
Actual
15/12/2015
Sample size
Target
70
Accrual to date
Final
132
Recruitment outside Australia
Country [1] 8400 0
Turkey
State/province [1] 8400 0
Aydin

Funding & Sponsors
Funding source category [1] 294996 0
University
Name [1] 294996 0
The Adnan Menderes University, Efeler. Aydin
Country [1] 294996 0
Turkey
Primary sponsor type
Individual
Name
Keziban Amanak
Address
Adnan Menderes Universiy, Health Science Fakulty, Midwifery Department, Hasan Efendi Neighborhood, Genclik Street,. No:7, 09100 Efeler; Aydin,
Country
Turkey
Secondary sponsor category [1] 293814 0
Individual
Name [1] 293814 0
Umran Sevil
Address [1] 293814 0
Ege University, Nursing Faculty,
Women's Health and Diseases Nursing Department, Kazimdirik Neighborhood, Erzene Street, No: 1, 35100, Bornova; Izmir,
Country [1] 293814 0
Turkey
Secondary sponsor category [2] 293815 0
Individual
Name [2] 293815 0
Zekiye Karacam
Address [2] 293815 0
Adnan Menderes Universiy, Health Science Fakulty, Midwifery Department, Hasan Efendi Neighborhood, Genclik Street,. No:7, 09100 Aydin.
Country [2] 293815 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296350 0
Ege University Nursing Faculty Scientific Ethics Committee
Ethics committee address [1] 296350 0
Ethics committee country [1] 296350 0
Turkey
Date submitted for ethics approval [1] 296350 0
Approval date [1] 296350 0
11/09/2013
Ethics approval number [1] 296350 0
2013-36

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70546 0
Dr Keziban Amanak
Address 70546 0
Adnan Menderes Universiy, Health Science Fakulty, Midwifery Department, Hasan Efendi Neighborhood, Genclik Street,. No:7, 09100 Aydin.
Country 70546 0
Turkey
Phone 70546 0
+90 2562138866
Fax 70546 0
Email 70546 0
[email protected]
Contact person for public queries
Name 70547 0
Keziban Amanak
Address 70547 0
Adnan Menderes Universiy, Health Science Fakulty, Midwifery Department, Hasan Efendi Neighborhood, Genclik Street,. No:7, 09100 Aydin.
Country 70547 0
Turkey
Phone 70547 0
+90 2562138866
Fax 70547 0
Email 70547 0
[email protected]
Contact person for scientific queries
Name 70548 0
Keziban Amanak
Address 70548 0
Adnan Menderes Universiy, Health Science Fakulty, Midwifery Department, Hasan Efendi Neighborhood, Genclik Street,. No:7, 09100 Aydin.
Country 70548 0
Turkey
Phone 70548 0
+90 2562138866
Fax 70548 0
Email 70548 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe impact of prenatal education based on the roy adaptation model on gestational hypertension, adaptation to pregnancy and pregnancy outcomes.2019
N.B. These documents automatically identified may not have been verified by the study sponsor.