The Effect of Education Given to Pregnancy on Prenatal Attachment, Anxiety and Fear of Birth
1 other identifier
interventional
62
1 country
1
Brief Summary
Communication between nurse and patient is considered essential to provide holistic and humane care as it allows patients to be fully understood, assisted, and their needs defined as empathetic. Travelbee, states that nursing is conducted through human-to-human relationships. These relationships begin first with the encounter of the nurse and the patient, then with the stage of emergence of identities where the relationship begins, the stage in which the nurse and the patient perceive each other's uniqueness, the empathy stage in which the person shares their experiences, the sympathy stage in which the nurse wants to reduce the cause of the patient's pain, and the final stage is the nurse and the patient's interrelated thoughts and feelings, their interest and concern towards others, a non-judgmental attitude and a person specific to each individual it consists of the stage of harmony that he approaches with respect. During this biological process, many physiological and psychological changes can be expected in pregnant women. Many psychological and social factors influence the fear of childbirth. These factors include; Lack of self-confidence in childbirth, being affected by negative birth histories, history of depression, anxiety, partner dissatisfaction, young maternal age, low income level, low education and low perception of social support, pain in childbirth or fear of losing control, and physical injury during childbirth. It is also possible that the fear of childbirth and the appearance of symptoms of stress and anxiety, which complicates pregnancy. Mother-infant bonding, which is adversely affected by mental problems such as anxiety, depression and fear of childbirth during pregnancy, can adversely affect the attachment process in both prenatal period. There are some non-pharmaceutical applications to strengthen the mental health of the mother, to reduce stress and fear of childbirth, and to strengthen the mother-baby bond. These are practices that include listening to music, psychoeducation, cognitive and behavioral therapies. With professional support in this study, childbirth will take place in a completely safe environment where stress and fear of childbirth are less. Nurses need to communicate from person to person in order to achieve the goal of effective care and to be healing. The training program was created based on Travelbee's five-step human-to-human relationship model with pregnant women who fear childbirth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 3, 2023
CompletedFirst Submitted
Initial submission to the registry
July 12, 2023
CompletedFirst Posted
Study publicly available on registry
August 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 21, 2023
CompletedOctober 10, 2023
October 1, 2023
2 months
July 12, 2023
October 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Wijma Birth Expectation/Experience Scale (W-DEQ) Version A
It is a scale developed to determine the birth fear and stress of pregnant women. W-DEQ version A is a 6-point Likert-type scale consisting of 33 items. While the minimum score on the scale is 0, the maximum score is 165. The negatively charged questions (2, 3, 6, 7, 8, 11, 12, 15, 19, 20, 24, 25, 27, 31) in the scale are calculated by reversing them. A high score indicates a high level of fear of childbirth. The cutoff point is 85. A score of 85 and above indicates clinical fear of childbirth. The Cronbach's Alpha value of the scale was found to be 0.88 for primiparous pregnants and 0.90 for multiparous pregnants. * 0-37 points = mild fear of childbirth * 38-65 points = moderate fear of childbirth * 66-84 points = severe fear of childbirth * 85 and above = clinical fear of childbirth
each participant pregnant will be evaluated for outcome measure for four weeks
Beck Anxiety Scale (BAI)
It is a scale developed to measure anxiety symptoms and reveal the cognitive aspects of anxiety. The scale consists of 21 items and is a four-point Likert type scale scored between 0-3. The lowest 0 and the highest 63 points are obtained in the scale. For each item, it is required to tick one of the options "None", "Mild", "Moderate", "Severe". 13 items evaluate physiological symptoms, 5 items describe the cognitive aspect, 3 items represent both somatic and cognitive symptoms. The high total score obtained in the scale indicates the severity of the anxiety experienced by the individual. The Cronbach alpha value of the scale was found to be 0.93.
each participant pregnant will be evaluated for outcome measure for four weeks
Prenatal Attachment Inventory (PAI)
Prenatal attachment inventory was developed to explain the thoughts, feelings and experiences of pregnant women and to determine mother-baby attachment levels. The scale is applied to pregnant women in the 20th and 40th weeks of pregnancy. The scale consists of 21 items. A minimum of 21 points and a maximum of 84 points can be obtained from the scale. An increase in the score indicates that the level of attachment to the baby also increases. The Cronbach Alpha reliability coefficient of the scale was stated as 0.84.
each participant pregnant will be evaluated for outcome measure for four weeks
Study Arms (2)
intervention group
EXPERIMENTALThis group will consist of 35 primiparous pregnant women. The training program, prepared in line with travelbe's human-human relations model, will continue for a total of 4 weeks, 2 days a week.
control group
NO INTERVENTIONThis group will consist of 35 primiparous pregnant women. No training program will be given to this group and routine pregnant follow-up will continue.
Interventions
human-to-human communication and psychoeducation-assisted birth preparation training
Eligibility Criteria
You may qualify if:
- years and over.
- At least primary school graduate.
- According to the last menstrual period or for pregnant women who do not know the last menstruation date, to be between 20-34 weeks in the calculations made with USG data.
- Intermediate and higher score on the Wijma birth expectancy/experience scale version A.
- Having a single and live pregnancy.
- Having your first pregnancy.
- Agreeing to participate in the research.
- Having trouble communicating.
- No infertility treatment.
- No contraindications for vaginal delivery
You may not qualify if:
- Pregnant women with medical indications.
- Those with high-risk pregnancies.
- Having given birth before.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tuğba Sarılead
Study Sites (1)
Yozgat City Hospital
Yozgat, 66000, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tuğba Sarı, Nurse
Yozgat City Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor Investigator
Study Record Dates
First Submitted
July 12, 2023
First Posted
August 1, 2023
Study Start
July 3, 2023
Primary Completion
September 11, 2023
Study Completion
September 21, 2023
Last Updated
October 10, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- starting 6 months after publication
- Access Criteria
- Only the collected data will be shared for analysis.
All IPD collected and affecting the outcome of the study will be published