Reduction of Pre-operative Anxiety Using a Specially Designed Educational Program for Breast Cancer Patients Undergoing Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Patient Pre-Operative Anxiety
研究概览
简要总结
This study aims to find out that if a specially designed educational program can help in reduction of pre-operative anxiety in breast cancer patients undergoing surgery as a part of their treatment.
详细描述
Anxiety can be defined as an unpleasant subjective experience associated with the perception of real threat; therefore, it is a common symptom in connection with cancer. Breast Cancer patients undergo surgery at some stage of their treatment, Surgery details can be overwhelming and might lead to low retention of information and greater levels of anxiety which is the most prevalent psychological symptoms perceived by cancer patients.
Studies have shown women with a diagnosis of cancer correlate with higher levels of preoperative anxiety. Increased anxiety elicits physiologic stress responses that may impede healing and alter responses to postoperative pain.It can also lead to delayed recovery, prolonged hospital stay and increased need of postoperative pain medications.
Pre-Operative Anxiety may also cause delayed recovery from Anesthesia and can also compromise the effectiveness of anesthesia .Furthermore, it can lead to other post-operative complications such as nausea, vomiting, and delayed wound healing. Various Pharmacological and non-pharmacological methods have been used for reduction of pre-operative anxiety and one such non-pharmacological method is educating the patients about the experience of surgery pre-operatively which we aim to study in our population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
It would be a "single blinded study" the assessor will be blinded to the type of group to which patient belongs.
Blinding will be ensured by sharing the data only with relevant study team members, The assessor will read out instruction before beginning of the interview requesting the enrolled patients not to mention the tools used for pre-operative education and to answer only the questions being asked.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 to 70 years of age.
- •Known cases of Breast Cancer.
- •Undergoing Breast Surgery as a part of treatment.
- •Availability of Personal smart phone at home.
- •Written informed Consent given for participation in trial.
排除标准
- •Less than 18 years or more than 70 years of age.
- •Stage IV patients undergoing palliative breast surgery.
- •Patient having chronic pain.
- •Un-availability of smart phone.
- •Patients with known psychiatric/depression disorders.
- •Previous history of another treated carcinoma.
- •Patients with re-current breast carcinoma.
- •Male Patients are excluded from study.
结局指标
主要结局
Patient Pre-Operative Anxiety
时间窗: 6 months
This will be measured by using The Perioperative Anxiety Scale-7 (PAS-7), PAS 7 is a validated tool which includes seven items. This tool was developed by Zhang, C., Liu, X., Hu, T. et al. at Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China. Permissions were obtained and granted for use of PAS 7 in this project and its translation into Urdu. The process of translation involved forward translation by two independent translators, formation of a reconciled version by third translator, Back translation, independent review and finalization.
次要结局
- Patient Satisfaction.(6 Months)
研究者
Dr. Muhammad Awais Kanwal
Dr. Muhammad Awais Kanwal
Shaukat Khanum Memorial Cancer Hospital & Research Centre