Condition category
Pregnancy and Childbirth
Date applied
25/07/2008
Date assigned
31/07/2008
Last edited
26/01/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Hyam Bashour

ORCID ID

Contact details

Faculty of Medicine
Damascus University
P.O.Box 9241
Damascus
9241
Syria
+963 11 6618328
hbashour@aloola.sy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

074986; 72

Study information

Scientific title

Effect of doctors' training in interpersonal and communication skills on women's satisfaction at labour and delivery: a stepped wedge cluster randomised trial in Damascus

Acronym

Study hypothesis

Training residents in interpersonal and communication skills would improve women's satisfaction with patient-doctor relationship in labour and delivery rooms.

Ethics approval

Ethics approval received from the Institutional Review Board at Damascus University, Faculty of Medicine on the 28th March 2006 (ref: 671).

Study design

A stepped wedge randomised controlled design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Women satisfaction with maternity care

Intervention

In the stepped wedged design which is known to be ethically sensitive all will be exposed to intervention by the end of the trial. The timing in which each hospital will receive the intervention (stepping) is randomised. The intervention is a training package which was designed by an international expert in communication skills with activities and role plays based on real example from the maternity wards that were collected from previous research. All residents in the study hospitals will be exposed to training, not necessary at a single point of time as the number of residents in some hospitals is very big to be trained at one time. The training will cover the following themes:
1. An overview of the doctor-patient communication
2. Questioning skills
3. Listening skills
4. Non-verbal communication
5. Answering skills
6. Rapport building skills
7. Counselling skills
8. Skills of persuasion

Effective teaching methods will be used as suggested by Maguire and Pitceathly (2002). The training is carried out by an Arab speaker for three days and 20 hours of training.

The measurement of outcomes will be carried out after the training in each hospital as well as 2 and 6 months afterwards. Rounds of observation will be done, where each round will include an observation in all rooms, for 3 days and for all shifts including day and night shifts. As for the women satisfaction questionnaire; this will be implemented as well in four points of times excluding the baseline. Nearly one hundred women will be recruited from each hospital. Also, future measurements at 2 and 6 months after the study are considered but will not be part of this study. Thus the expected duration for the intervention in the clusters of hospitals and the measurement will take about 12 months.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Women's satisfaction with interpersonal relationships of doctors working in labour and delivery rooms.

The measurement of outcomes will be carried out after the training in each hospital as well as 2 and 6 months afterwards.

Secondary outcome measures

Change in communicative behaviour of the care providers (residents) serving in labour and delivery rooms.

The measurement of outcomes will be carried out after the training in each hospital as well as 2 and 6 months afterwards.

Overall trial start date

01/07/2008

Overall trial end date

01/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Care providers including mainly residents working in the public maternity hospitals in Damascus and its surroundings
2. Women as potential beneficiaries from our intervention would include all women (aged 15 - 49 years) using the hospitals under study. We will target in our measurements all women with living babies who agreed to participate in the study, whether the delivery was normal vaginal or by caesarean section. Women using those hospitals are largely from middle and low socio-economic class.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

2000 women and 200 care providers

Participant exclusion criteria

All care providers and women who do not meet the inclusion criteria

Recruitment start date

01/07/2008

Recruitment end date

01/12/2009

Locations

Countries of recruitment

Syria

Trial participating centre

Faculty of Medicine
Damascus
9241
Syria

Sponsor information

Organisation

Faculty of Health Sciences/American University of Beirut (Lebanon)

Sponsor details

PO Box 11-0236
Riad El Solh
Beirut
1107 2020
Lebanon
+961 (0)1 347 444
crph@aub.edu.lb

Sponsor type

University/education

Website

http://www.aub.edu.lb/

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 074986) - funding provided to the Faculty of Health Sciences/American University of Beirut (Lebanon) for the programme on Choices and Challenges in Changing Childbirth

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes