To assess the effectiveness of psychological counselling in reducing psychological morbidity after miscarriage
| ISRCTN | ISRCTN64429365 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64429365 |
| Secondary identifying numbers | CRE-2000.233 |
- Submission date
- 02/08/2013
- Registration date
- 23/08/2013
- Last edited
- 24/02/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Whilst psychological distress after a miscarriage can be significant and enduring, women are not routinely provided with professional psychological support or any follow-up care. The purpose of this study is to find out how well psychological counselling works in reducing psychological distress after miscarriage.
Who can participate?
Miscarrying women in the Prince of Wales Hospital, Hong Kong are eligible to participate in the study.
What does the study involve?
Patients are randomly allocated to one of two groups: either psychological counselling or routine management without psychological counselling. The counselling group receives a psychological counselling programme conducted in two sessions, one when they are still in the hospital and the second, two weeks after the miscarriage. They are asked to fill in some questionnaires at 6 weeks, 3 months and 6 months after the miscarriage to find out how well the counselling has worked.
What are the possible benefits and risks of participating?
The participants do not have any benefit and risks of taking part in the study.
Where is the study run from?
Prince of Wales Hospital, Hong Kong.
When is the study starting and how long is it expected to run for?
This study started in 2005 and finished in 2006.
Who is funding the study?
This study is funded by the Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong.
Who is the main contact?
Dr Grace Wing Shan Kong
gracekong@cuhk.edu.hk
Contact information
Scientific
1E, Department of Obstetrics and Gynaecology
Prince of Wales Hospital
Shatin
HKSAR
Hong Kong
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised controlled trial of psychological counselling on psychological morbidity after miscarriage |
| Study objectives | Psychological counselling reduces the proportion of patients with psychological morbidity following miscarriage. |
| Ethics approval(s) | This study is approved by Joint The Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee with CREC Ref. No: CRE-2000.233 in 2003 |
| Health condition(s) or problem(s) studied | Miscarriage |
| Intervention | For the randomization, patients who agreed to participate in the study gave written consent and were then randomised using a set of sealed, opaque, sequentially numbered envelopes, each containing a computer-generated random number denoting the randomisation result. Randomisation was into one of the following two groups: Group 1 (Counselling group): Patient in this group received psychological counselling from a nurse counsellor after completion of baseline questionnaires in the hospital before discharge. They were then followed up by the nurse counsellor two weeks later by telephone to reinforce the counselling. Group 2 (Control group): Patient in this group were managed according to our routine clinical practice and attended by the clinical staff as usual. No specific counselling or follow-up care was arranged. For the intervention, the counselling programme comprised of two sessions. The first session usually lasted about 60 minutes and was conducted while the patient was still in hospital. The second session usually lasted about 30 minutes and was conducted two weeks after miscarriage. This session thus aimed at reinforcing the previous information given; to allow the patient to discuss her feelings, worries and physical concerns; to discover possible underlying stress factors. We adopted telephone conselling format mainly for the convenience of the patient. |
| Intervention type | Behavioural |
| Primary outcome measure | The psychological morbidity [General Health Questionnaire (GHQ-12) and Beck Depression Inventory (BDI) questionnaires] following miscarriage The psychological outcomes (proportion of patients suffering psychological morbidity and the median psychometric scores) at baseline, six weeks, three months and six months after miscarriage of both counselling group and control group were evaluated. |
| Secondary outcome measures | The interaction between time and psychological intervention on the psychometric outcome were assessed. |
| Overall study start date | 01/02/2004 |
| Completion date | 31/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 40 Years |
| Sex | Female |
| Target number of participants | 280 |
| Key inclusion criteria | Women aged 18-40 admitted with the diagnosis of miscarriage |
| Key exclusion criteria | 1. Patient who were unwilling to participate 2. Patient with psychiatric disease requiring active treatment 3. Patient who were non-Chinese 4. Patient who were visitors to Hong Kong (e.g. tourists for whom arranging follow-up would be difficult) |
| Date of first enrolment | 01/02/2004 |
| Date of final enrolment | 31/01/2005 |
Locations
Countries of recruitment
- Hong Kong
Study participating centre
HKSAR
Hong Kong
Sponsor information
Hospital/treatment centre
1E, Department of Obstetrics and Gynaecology
Prince of Wales Hospital
Shatin
HKSAR
Hong Kong
"ROR" |
https://ror.org/00t33hh48 |
|---|
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- The Chinese University of Hong Kong, 香港中文大学, CUHK
- Location
- Hong Kong
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2014 | Yes | No |
