A randomized controlled trial examining the effectiveness of a STOMA psychosocial intervention programme on the outcomes of colorectal patients with a stoma: study protocol

Aims: To report a study protocol that evaluates the effects of a psychosocial intervention on patients with a newly formed stoma. Background: With the loss of a significant body function and distorted body image, stoma patients experience physical, psychological and social challenges. Nurses have an important role in helping patients' make a smooth transition to living with their stoma. Limited studies have examined the effects of psychosocial interventions on improving stoma-related health outcomes. Design: A randomized controlled trial is planned. Methods: Eighty-four patients with newly formed stoma in a tertiary hospital in Singapore (Research Ethics Committee approval obtained in January 2013) will be recruited. Participants will be randomly assigned to either a control group who receive routine care or an intervention group who receive STOMA psychosocial intervention besides routine care. Outcome variables include stoma care self-efficacy, days to stoma proficiency, length of hospital stay, acceptance of stoma, anxiety and depression and quality of life. Data will be collected at four time points: before randomization and intervention (baseline), on the day of discharge (mid-intervention), at 4\ua0weeks after discharge (postintervention 1) and at 4\ua0months after discharge (postintervention 2). Discussion: This study will develop a psychosocial intervention programme, which may improve patients' stoma-related outcomes. The findings will provide direction to health professionals about education and the type of support that could be offered to patients concerning stoma care in the hospital setting, which will eventually improve their quality of life