Reduction of Pre-operative Anxiety Using a Specially Designed Educational Program for Breast Cancer Patients Undergoing Surgery: a Randomized Controlled Trial (PAUSDE)

Shaukat Khanum Memorial Cancer Hospital & Research Centre

Status: Invitation-only

Conditions: Patient Satisfaction; Anxiety; Preoperative Anxiety

Treatments: Other: comprehensive educational program for reduction of Pre-Operative Anxiety

Study type: Interventional

Funder types: Other

Identifiers

NCT05887856

IRB-22-40

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 to 70 years of age.
2. Known cases of Breast Cancer.
3. Undergoing Breast Surgery as a part of treatment.
4. Availability of Personal smart phone at home.
5. Written informed Consent given for participation in trial.
6. Females.

Exclusion criteria

1. Less than 18 years or more than 70 years of age.
2. Stage IV patients undergoing palliative breast surgery.
3. Patient having chronic pain.
4. Un-availability of smart phone.
5. Patients with known psychiatric/depression disorders.
6. Previous history of another treated carcinoma.
7. Patients with re-current breast carcinoma.
8. Male Patients are excluded from study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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400 participants in 2 patient groups

Intervention Group

Active Comparator group

Description:

Volunteers in the Intervention group will receive specially designed educational program which will be aimed at reduction of pre-operative anxiety in breast cancer patients undergoing surgery as a part of their treatment.

Treatment:

Other: comprehensive educational program for reduction of Pre-Operative Anxiety

Non-Intervention Group

No Intervention group

Description:

Non-Intervention group will get the usual standard information as per existing protocols which includes 1. Explanation of surgical procedure by primary team. 2. Information about anesthesia on pre-operative anesthesia assessment. 3. Phone call from Primary team explaining surgery details one day prior to surgery in case of day case surgery. 4. Information about surgery on admission from floor resident in case of Pre-Op Admission. Afore mentioned practices are standard at SKMCH and RC and will remain same for both intervention and non-intervention group.