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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 13 January 2020
Main ID:  ACTRN12614000120673
Date of registration: 31/01/2014
Prospective Registration: No
Primary sponsor: Dr. Emmanuel Achime
Public title: Influence of child birthing audiovisuals on anxiety and obstetric outcomes of first time mothers in Ibadan: a randomized controlled trial
Scientific title: Influence of child birthing audiovisuals on anxiety and obstetric outcomes of primigravid women during antenatal clinic in Ibadan: a randomized controlled trial
Date of first enrolment: 06/08/2012
Target sample size: 120
Recruitment status: Completed
URL:  https://anzctr.org.au/ACTRN12614000120673.aspx
Study type:  Interventional
Study design:  Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;  
Phase:  Not Applicable
Countries of recruitment
Nigeria
Contacts
Name: Dr Imran Morhason-Bello   
Address:  Department of Obstetrics and Gynaecology, Faculty of Clinical Sciences, College of Medicine, University of Ibadan/University College Hospital, PMB 5116, Queen Elizabeth Road, Ibadan, Oyo State Nigeria
Telephone: +234 803 478 4402
Email: onembello@yahoo.co.uk
Affiliation: 
Name: Dr Imran Morhason-Bello   
Address:  Department of Obstetrics and Gynaecology, Faculty of Clinical Sciences, College of Medicine, University of Ibadan/University College Hospital, PMB 5116, Queen Elizabeth Road, Ibadan, Oyo State Nigeria
Telephone: + 234 803 478 4402
Email: onembello@yahoo.co.uk
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: 1. Primigravid/ nulliparous pregnant women
2. Anticipated vaginal delivery
3. Absence of medical disorders (hypertension, Diabetes Mellitus)
4. Singleton foetus in the current pregnancy
5. 28 -30 weeks gestation

Exclusion criteria: 1. Those that decline to participate in the study
2. Presence of multiple pregnancies
3. Fetal malpresentations
4. Other obstetric indications that could contraindicate vaginal delivery


Age minimum: No limit
Age maximum: No limit
Gender: Females
Health Condition(s) or Problem(s) studied
Reproductive Health and Childbirth - Childbirth and postnatal care
anxiety level;obstetric outcome;
anxiety level
obstetric outcome
Mental Health - Anxiety
Intervention(s)
Apart from the routine antenatal care service, the intervention group watched a five minutes documentary film on the events that occur during the second stage of labour. This was shown to those in the experimental group after recruitment and assessment of baseline anxiety levels. Questions and clarifications were made during the course of the session to dispel misconceptions and improve knowledge among respondents in the experimental group.
Primary Outcome(s)
The primary outcome is to measure the change in level of anxiety in the treatment/intervention arm compared to the controls. The State Trait Anxiety Inventory for Adults (STAI) was used to measure the anxiety level.The STAI was administered to assess the state of anxiety and trait anxiety and consists of 20 questions on current feeling of anxiety (state) and usual feeling of anxiety (trait). Feelings of anxiety were rated on a likert scale of 1 (not at all) to 4 (very much so) for each question. Scores were summed, and ranged between 20-80. [assessed at baseline (34 weeks gestation), at 37 weeks gestation and immediately after childbirth ]
Secondary Outcome(s)
The secondary outcome is to measure the change in obstetric outcomes - duration of active phase of labour in hours, mode of delivery (vaginal versus caesarean) and apgar score - for those in the treatment arm compared to those in the control arm[This is monitored on the day of delivery before discharge from the hospital]
Secondary ID(s)
NONE
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
University of Ibadan/University College Hospital Ethical Review Committee
Results
Results available:
Date Posted:
Date Completed:
URL:
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