Clinical trial NCT05887856: Reduction of Pre-operative Anxiety Using a Specially Designed Educational Program for Breast Cancer Patients Undergoing Surgery: a Randomized Controlled Trial
Official title: Reduction of Pre-operative Anxiety Using a Specially Designed Educational Program for Breast Cancer Patients Undergoing Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Patient Satisfaction
Preoperative Anxiety
Anxiety
Lead sponsor: Shaukat Khanum Memorial Cancer Hospital & Research Centre
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pre-operative randomization after enrollment will be carried out and patients will be allocated either to the "intervention group" or to the "non-intervention group "by 'computerized block randomization'. Research Randomizer software, a free to use software will be used for this. Patients will be randomized either into the intervention group or into non-intervention group.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Pre-Operative Anxiety
timeFrame: 6 months
Secondary outcomes:
measure: Patient Satisfaction.
timeFrame: 6 Months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Shaukat Khanum memorial cancer hospital and research centre
Study officials:
affiliation: Shaukat Khanum memorial cancer hospital and research centre lahore
name: Dr. Barka Sajjad, M.B.B.S, FCPS, MRCS
role: PRINCIPAL_INVESTIGATOR
References: