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. 2018 Sep 24:4:150.
doi: 10.1186/s40814-018-0341-1. eCollection 2018.

Study protocol: a pilot randomized controlled trial to evaluate the acceptability and feasibility of a counseling intervention, delivered by nurses, for those who have attempted self-poisoning in Sri Lanka

A N L M De Silva  1 , Andrew H Dawson  2 , Indika B Gawarammana  3 , Sampath Tennakoon  4 , Thilini Rajapakse  5
Affiliations

Study protocol: a pilot randomized controlled trial to evaluate the acceptability and feasibility of a counseling intervention, delivered by nurses, for those who have attempted self-poisoning in Sri Lanka

A N L M De Silva et al. Pilot Feasibility Stud. .

Abstract

Background: Deliberate self-harm in the form of non-fatal self-poisoning is a major public health problem in Sri Lanka. Previous work suggests that many nurses in Sri Lanka-particularly those who work in primary care in the medical treatment of persons who attempt self-poisoning-already approach their role in a holistic fashion and consider "advising" or "counseling" patients after self-poisoning to be a part of their nursing role. But there is no formal training given to such nurses at present nor has the efficacy or feasibility of such an intervention been assessed in Sri Lanka. The aims of this pilot study are to explore the potential efficacy, acceptability, and feasibility of carrying out a counseling intervention that could be delivered by nurses for persons who present to hospital for medical management of non-fatal self-poisoning.

Methods/design: The study will be carried out at the Toxicology Unit of Teaching Hospital Peradeniya, Sri Lanka. A pilot randomized controlled trial will be carried out among participants admitted to Teaching Hospital Peradeniya for medical management of non-fatal self-poisoning. The primary objective of this study is to explore the acceptability and feasibility of a counseling intervention being delivered by nurses. The secondary objectives are to explore the efficacy of the intervention for the improvement of skills to cope with situations of acute emotional distress, and to reduce rates of anxiety, depression, and future repetition and suicidal ideation. A nurse's experiences and attitudes regarding the acceptability and feasibility of implementing this intervention and participant experiences of the intervention and its effects will be explored via qualitative interviews and focus group discussions.

Discussion: It is anticipated that the findings of this pilot study will help determine and assess the acceptability and feasibility of this counseling intervention, as well as indicate the more useful aspects of this intervention in order to develop it for further exploration in a larger trial.

Trial registration: SLCTR/2017/008 Registered on 21st March 2017.

Keywords: Counseling; Non-fatal self-poisoning; Nursing.

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Conflict of interest statement

Ethical approval for this study has been obtained from the Ethical Review Committee of the Faculty of Medicine, University of Peradeniya (2016/EC/81). The trial has been registered at the Sri Lanka Clinical Trials Registry (SLCTR/2017/008). The trial has been designed according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 checklist and followed the CONSORT extension for pilot trials in planning the RCT [47]. All interviews and assessments of participants (who have recently attempted self-harm) will be conducted in a confidential setting. Every effort will be taken to ensure that there is no interruption or adverse effect to the treatment as usual received by all participants (cases and controls). When relevant participants will be offered and referred to further psychiatric care and follow-up. All data regarding those who have attempted self-poisoning will be kept strictly confidential, and all hard and soft copy data sheets will be stored securely, with only the researchers having access.Not applicableThe authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study flow chart
See this image and copyright information in PMC

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