Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000120673
Ethics application status
Approved
Date submitted
1/01/2014
Date registered
31/01/2014
Date last updated
31/01/2014
Type of registration
Retrospectively registered

Titles & IDs
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
Secondary ID [1] 283825 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anxiety level 290801 0
obstetric outcome 291032 0
Condition category
Condition code
Reproductive Health and Childbirth 291167 291167 0 0
Childbirth and postnatal care
Mental Health 291168 291168 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 288511 0
Other interventions
Comparator / control treatment
Only had routine antenatal care service
Control group
Active

Outcomes
Primary outcome [1] 291156 0
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.
Timepoint [1] 291156 0
assessed at baseline (34 weeks gestation), at 37 weeks gestation and immediately after childbirth
Secondary outcome [1] 306153 0
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
Timepoint [1] 306153 0
This is monitored on the day of delivery before discharge from the hospital

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key 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

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)
On each clinic day, consenting women that met the inclusion criteria were given serial numbers with allotted treatment group based on their arrival time. Only the RAs had access to the list of numbers used to prevent clinicians’ influence on the randomisation. Each subject opened the opaque envelope in the presence of the RAs, and the assigned treatment group was recorded in the RAs records while an identification number was given and recorded on the medical file. The research protocol was closely monitored by the RAs to avoid bias and also, to ensure that all subjects are assigned to treatment groups. Those administering the proforma and assessing the outcomes were blinded to the groups to which participants belonged.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible participants that accepted to be part of the study were recruited into the trial and randomized into two groups. The randomisation sequence was generated using Random Allocation Software, Version 1.0, 2004. Random permuted blocks of size four were used to ensure a balanced design. The blocks are the possible permutations of a sequence of four allocations – two women each belonging to the experimental and control groups. Based on the sequence of treatments generated using this method, treatment groups (A and B) were written on pieces of cardboard paper and put into sealed opaque envelopes. Each of the opaque envelopes had a serial number on it. Two trained research assistants (RAs) non-medical staff supervised the randomisation procedure at every antenatal clinic (ANC).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was calculated with an intention to detect a minimum difference of five in anxiety levels between the groups at 80% power and alpha error of 0.05. This resulted in a sample size of 80. We estimated that about 30% of the women may be lost to follow up, there for sample size was adjusted for and we arrived at 114 (57 in each group). This was rounded up to 120 (60 in each group).

Data collection was done using three instruments (Questionnaire, State Trait Anxiety Inventory and visual analogue scale for anxiety-VAS-A). The questionnaire was an interviewer-administered semi-structured questionnaire consisting of two sections. Section one obtained information on baseline socio demographic characteristics of trial participants, while section two obtained information on the antenatal history.
The State Trait Anxiety Inventory for Adults (STAI) and Visual analogue Scale was used to measure anxiety. The visual analogue for anxiety assessed anxiety level using a standardized pictorial estimate. The State–Trait Anxiety Inventory for Adults (STAI), measures current anxiety and reflects current subjective feelings with respect to tension, apprehension, nervousness, and worry. The STAI was administered to assess the state of anxiety and trait anxiety and consists of 20 questions on present current feeling of anxiety (state) and usual feeling of anxiety (trait). Feelings of anxiety were rated on a scale of 1 (not at all) to 4 (very much so) for each question. Scores were summed, and ranged between 20-80. For all participants enrolled and randomized for the study, baseline information was obtained and anxiety assessment performed using the two scales. Thereafter, serial anxiety assessment was performed for both treatment arms (intervention and control) at 34 weeks, 37 weeks. After childbirth, obstetric/neonatal outcomes and anxiety assessment was done for all participants. This assessment was done by an assessor who was blinded to the groups to which the study participants belonged (intervention and control).

The data was coded, entered, cleaned, and analyzed using Statistical Product and Services Solutions (SPSS) for windows version 18.0.1. Demographic data and clinical characteristics were summarized as the mean +/- standard deviation for continuous variables and as frequency counts (percentages) for categorical variables. The independent groups t test and the chi-square test was used, as appropriate, to analyze group differences.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/08/2012
Actual
6/08/2012
Date of last participant enrolment
Anticipated
4/04/2013
Actual
25/04/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 5706 0
Nigeria
State/province [1] 5706 0
Oyo State / Ibadan

Funding & Sponsors
Funding source category [1] 288485 0
Self funded/Unfunded
Name [1] 288485 0
Country [1] 288485 0
Primary sponsor type
Individual
Name
Dr. Emmanuel Achime
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
Country
Nigeria
Secondary sponsor category [1] 287187 0
None
Name [1] 287187 0
Address [1] 287187 0
Country [1] 287187 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290348 0
University of Ibadan/University College Hospital Ethical Review Committee
Ethics committee address [1] 290348 0
Ethics committee country [1] 290348 0
Nigeria
Date submitted for ethics approval [1] 290348 0
Approval date [1] 290348 0
17/07/2012
Ethics approval number [1] 290348 0
UI/EC/12/0112 (UI/UCH/EC registration number: NHREC/05/01/2008a)

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

Contacts
Principal investigator
Name 45222 0
Dr Emmanuel Achime
Address 45222 0
Department of Obstetrics and Gynaecology,
University College Hospital, PMB 5116, Queen Elizabeth Road,
Ibadan, Oyo State
Country 45222 0
Nigeria
Phone 45222 0
+234 803 474 3988
Fax 45222 0
Email 45222 0
emmaachime @yahoo.com
Contact person for public queries
Name 45223 0
Imran Morhason-Bello
Address 45223 0
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
Country 45223 0
Nigeria
Phone 45223 0
+234 803 478 4402
Fax 45223 0
Email 45223 0
[email protected]
Contact person for scientific queries
Name 45224 0
Imran Morhason-Bello
Address 45224 0
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
Country 45224 0
Nigeria
Phone 45224 0
+ 234 803 478 4402
Fax 45224 0
Email 45224 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
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Documents added automatically
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