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Note: This record shows only the 20 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: SLCTR
Last refreshed on: 27 April 2013
Main ID:  SLCTR/2011/003
Date of registration: 26/01/2011
Primary sponsor: South Asian Clinical toxicology Research collaboration (SACTRC)
Public title: Developing a psychological and social management package and assessing its' benefits among snakebite victims
Scientific title: Development and assessment of a psycho-social intervention for snake bite victims
Date of first enrolment: 1/2/2011
Target sample size: 195 ( 65 snakebite victims in each group)
Recruitment status: Pending
URL:  http://www.slctr.lk/trial_details.asp?reg_id={FBBB758C-420C-4A9F-AF5E-0792A944683F}
Study type:  Interventional
Study design:  Type
Randomized, control clinical trial.
Setting
Snake bite victims will be recruited at the time of the bite from medical wards of the Polonnaruwa and Kurunegala general hospitals.
Duration
The total duration of the study will be 24 months. Data collection will start from January 2011.
Study Sample
All snake bite victims admitted to the above hospitals during the stipulated time period and identified as being envenomed and requiring treatment with anti-venom will be eligible for the study.
The recruits will then be randomized into three groups. Group 1 will be managed as at present and will receive no specific psycho-social intervention. This group will act as a control to the other groups receiving psycho-social interventions. The second group will receive a brief intervention in the form of psychological first aid and psycho-education at the time of discharge from hospital. The third group will receive the above brief intervention on discharge as w
 
Countries of recruitment
Sri Lanka
Contacts
Name: Dr. C. A. Wijesinghe 
Address:  P.O.Box 115 , Faculty of Medicine Ragama
Telephone: 0714818034/0112961115
Email: chamawij@hotmail.com
Affiliation:  Lecturer, Department of Psychiatry, Faculty of Medicine, Ragama
Name: Dr. C. A. Wijesinghe 
Address:  P.O.Box 115, Faculty of Medicine, Ragama
Telephone: 0714818034/0112961115
Email: chamawij@hotmail.com
Affiliation:  Lecturer, Department of Psychiatry, Faculty of Medicine, Ragama
Key inclusion & exclusion criteria
Inclusion criteria: Snakebite victims admitted to the Polonnaruwa General Hospital and Kurunegala Teaching Hospital with evidence of envenoming.
Exclusion criteria: Those with preexisting psychiatric disorders.

Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Depressive disorder, Post traumatic stress disorder , Somatization among snake bite victims
Intervention(s)
• Group 1- Normal management (No psychological intervention)

• Group 2 – Normal management + Psychological first aid + Psycho-education

• Group 3 – Normal management + Psychological first aid + Psycho-education + Brief intervention for PTSD

The psycho-social interventions will be conducted by trained pre-intern doctors. The rationale behind this is that we wish to develop a psychological intervention that can be administered by primary care physicians or junior ward doctors. The doctors conducting the intervention will be trained formally by a Psychiatrist on aspects pertaining to communication skills, specific psychological interventions and ethical issues in dealing with patients.
The specific types of psycho-social interventions provided will include:
1) Psychological First Aid:
• Comfort and consolation
• Sharing experience
• Facilitating a sense of being in control
• Identification of those in need of further help

2) Psycho-education:
• Discuss patients perceptions of snake bite and tackle myths related to snakebite and it’s consequences.
• Educate patients and relatives on the actual physical impact of snakebite and when to seek medical help.
• Make patients and family members aware of psychological symptoms of depression and post traumatic stress disorder and when to seek appropriate help.
• Educate on maladaptive coping methods such as avoidance behavior and maintenance of sick role seen following snake bite and the importance of rehabilitation within community.
• Brief trauma focused cognitive behavior therapy.

3) Brief Intervention for post traumatic stress disorder:
• Trauma based cognitive behaviour therapy
Primary Outcome(s)
Differences in Score of Hopkins symptoms checklist among three groups.

Differences in score of Modified Becks depression inventory among three groups.

Differences in score of Sheehan disability inventory among three groups.

Differences in scores of Post traumatic stress disorder symptom scale among three groups.
Secondary Outcome(s)
Effect on employment status

Effect on social life
Secondary ID(s)
Nil known
Source(s) of Monetary Support
South Asian Clinical toxicology Research collaboration (SACTRC)
Secondary Sponsor(s)
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