Feasibility and Acceptability of Medical Skin Camouflage for Recovery of Women With Self-Harm Scarring in Prison
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Warwick-Edinburgh Mental Well-being Scale
研究概览
简要总结
Women prisoners are more likely to commit suicide or self-harm than women in the community or male prisoners.
Healthcare services have improved how they manage self-harm in the community and prisons. However, there has been little focus on the recovery of people with self-harm scars. Medical skin camouflage (MSC) is a British National Formulary-listed topical cream designed to cover skin conditions. Research on MSC has focused on its use with non-self-harm marks e.g. burns. The evidence from this research suggests that the cream helps women feel better and do more activities. There is little/no evidence about the effects of the preparation for women who self-harm and for prisoners.
This research was funded by the National Institute for Health Research Research for Patient Benefit Programme. In the research the investigators will examine whether it is possible and practical to use MSC in prison. The investigators will ask women prisoners and staff what they think about the cream. The research has four parts. In the first part the investigators will run focus groups with women prisoners and prison staff to find out the best way to deliver the MSC intervention and how to measure its effects. In the second part the investigators will design a programme for delivering the MSC. The investigators will then train 6-10 long-term prisoners to become skin camouflage practitioners. The final part will involve a small randomised controlled trial with 40 women prisoners; 20 will be allocated to the intervention group and will use the MSC for 6 weeks. The investigators will measure their mood, thoughts of self-harm and wellbeing before and after they use MSC. The investigators will compare these results with 20 women who have not used MSC (waitlist control group). All women taking part will be placed at random into the control or the treatment group. The control group will receive the MSC after the research has ended.
Potential benefits of this study may be an increase in self-esteem and quality of life for the women prisoners. As women recover they may be less likely to self-harm.
详细描述
The study aims to establish the feasibility and acceptability of the use of medical skin camouflage for self-harm scarring in a women's prison. The investigators are interested in the use of medical skin camouflage by women who are recovering from self-harm. The research location is a Closed Category prison for female adults and young offenders in England. The study will involve adult women prisoners (over 18) and staff at the prison.
Medical Skin Camouflage uses specialised creams/powders to disguise skin conditions or scarring with the intention of normalising the appearance of the skin. Studies which have examined the use of medical skin camouflage for dermatological diseases or burns have reported significant psychological benefits and social benefits. Preliminary findings from co-applicant Dr Sandeep Ranote's work, with young people who self-harm in the community, indicate that the use of medical skin camouflage can lead to increased well-being, confidence and ability to partake in social activities. Currently there is no evidence on the use of MSC for self-harm scarring in prisons.
The research design is intended to provide information necessary to decide whether it is feasible and acceptable to conduct a full scale randomised controlled trial of MSC in a women's prison. The four phases of the research are as follows:
Phase 1: Focus groups in prison. Interested prisoners and staff will be provided with an information sheet about phase 1 of the project and will have up to 48 hours to decide whether they want to take part in this phase of the research. After consent the investigators will conduct 2 focus groups with women prisoners (including current self-harmers) and prison staff (6-10 in each group; 12-20 in total). The focus groups are designed to achieve two aims: to ensure that appropriate outcome measures are used in the phase four pilot trial; and to explore any barriers to the delivery of medical skin camouflage in a prison environment. The focus groups will last 60-90 minutes.
In the groups the investigators shall explore the following:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Remand and sentenced women prisoners screened for date of release with at least 6 weeks left on their sentence
- •Self-harm scarring, with closed wounds (to allow the MSC to be applied).
- •Able to give written, informed consent.
排除标准
- •Women prisoners with open wounds
- •Less than 6 weeks on anticipated release date
- •Women with skin conditions and allergies
- •Women prisoners who lack the capacity to consent to the research.
研究组 & 干预措施
Medical Skin Camouflage
This arm will use medical skin camouflage for 6 weeks
干预措施: Medical Skin Camouflage (Other)
Wait List Control
This arm will receive medical skin camouflage at the end of the study
结局指标
主要结局
Warwick-Edinburgh Mental Well-being Scale
时间窗: 6 weeks
WEMWBS, Minimum: 14 Maximum: 70. Higher scores represent higher mental wellbeing
次要结局
- Becks Hopelessness Scale(6 weeks)
- Adapted-DQLI(6 weeks)
- Becks Depression Inventory(6 weeks)
- Becks Scale for Suicidal Ideation(6 weeks)
- Rosenberg Self-Esteem Scale(6 weeks)
研究者
Kerry Gutridge
Project Manager
University of Manchester