Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000478516
Ethics application status
Approved
Date submitted
13/11/2006
Date registered
16/11/2006
Date last updated
16/11/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Providing parents in a neonatal intensive care unit with audiorecordings of their conversation with neonatologists: a randomised trial.
Scientific title
Providing parents in a neonatal intensive care unit with audiorecordings of their conversation with neonatologists: a randomised trial to assess whether such an adjunct in communication improves recall of information given by neonatologists, the maternal psychological well being (postnatal depression, anxiety score, general health) and parenting skills.
Universal Trial Number (UTN)
Trial acronym
TAPE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
1) Poor recall by mothers of information given by neonatologists. 1454 0
2) Maternal depression, anxiety, general health and parenting stress scales. 1455 0
Condition category
Condition code
Reproductive Health and Childbirth 1549 1549 0 0
Childbirth and postnatal care
Mental Health 1550 1550 0 0
Depression
Mental Health 1551 1551 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Providing mothers in Neonatal Intensive Care Unit with an audiotape of the conversation with the neonatologist.
After consent the first conversations (and subsequent of note as judged by the neonatologists: eg grade four intraventricular haemorrhage, patent ductus arteriosus and necrotising enterocolitis needing treatment, epilepsy) between mothers and neonatologist are audiotaped.

The mothers listened to the audiorecordings whenever they want to. The duration of the audiorecording average 25 minutes. The parents in the treatment arm of the study were given the audiotape to take home so that they can listen to it anytime and anywhere until the end of the study. The duration of the intervention was for 1 year.
Intervention groups. Mothers received a copy of the audiorecording and a portable "walkman" tape recorder for the mothers' use during the stay of the baby.
Intervention code [1] 1441 0
Treatment: Devices
Comparator / control treatment
Control: Mothers did not receive the audiotapes but were offered to have the audiotapes after the 1 year followup.
Control group
Active

Outcomes
Primary outcome [1] 2141 0
The mothers' recall of information were assessed after intervention by an interview conducted by the research nurse using a standard information recall proforma to assess the recall of information of the babies' diagnosis, tests, treatment and likely outcome.
Timepoint [1] 2141 0
Interviews were done at day 10, 4 months and 12 months. All recordings were transcribed within a week from the recordings by the research nurses. After completion of the trial all recordings were scored (by a neonatologist blinded to randomisation) for the information given (by the neonatologists during the conversations) on diagnosis, tests, treatments and likely outcome.
Secondary outcome [1] 3708 0
Psychological well being of mothers (post natal depression, anxiety state, general health and parenting stress).
Timepoint [1] 3708 0
Postnatal depression, anxiety score and general health were assessed at day 10, 4 months and 1 year follow up. Parenting stress at 1 year follow up.

Eligibility
Key inclusion criteria
Mothers were eligible for the study if their babies were admitted to the NICU, they understood English or had an interpreter and they consented to be recruited.
Minimum age
16 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Mothers were excluded if they were receiving psychiatric care or their baby needed to be transferred interstate during the first week of life.

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)
The researcher contacted a Clinical Trials Centre randomisation service and the parent was allocated to receive or not a copy of the audiotape.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule was generated using a computer sequence with variable blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The neonatologists were the clinicians as was the neonatal team. Two half time research nurses recruited, administered questionnaires / interviews and maintained database. The neonatologist who scored the recall of information was blinded to the randomisation.
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/1999
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1691 0
Charities/Societies/Foundations
Name [1] 1691 0
Royal Children’s Hospital Foundation (Grant No.749)
Country [1] 1691 0
Australia
Primary sponsor type
Individual
Name
Dr Andrew Johnson, The Townsville Hospital
Address
Country
Australia
Secondary sponsor category [1] 1492 0
Individual
Name [1] 1492 0
Professor P Butow, University of Sydney
Address [1] 1492 0
Country [1] 1492 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3140 0
The Townsville District Health Service Ethics Committee
Ethics committee address [1] 3140 0
Ethics committee country [1] 3140 0
Australia
Date submitted for ethics approval [1] 3140 0
Approval date [1] 3140 0
01/12/1998
Ethics approval number [1] 3140 0
62/98

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

Contacts
Principal investigator
Name 27375 0
Address 27375 0
Country 27375 0
Phone 27375 0
Fax 27375 0
Email 27375 0
Contact person for public queries
Name 10630 0
Dr Guan Koh
Address 10630 0
NICU, The Townsville Hospital, Douglas QLD 4814
Country 10630 0
Australia
Phone 10630 0
+61 7 47962985
Fax 10630 0
+61 7 47962981
Email 10630 0
Guan_koh@health.qld.gov.au
Contact person for scientific queries
Name 1558 0
Dr Guan Koh
Address 1558 0
NICU, The Townsville Hospital, Douglas QLD 4814
Country 1558 0
Australia
Phone 1558 0
+61 7 47962985
Fax 1558 0
+61 7 47962981
Email 1558 0
Guan_koh@health.qld.gov.au

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
No additional documents have been identified.