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Enrolling by invitation NCT05887856

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

No phase Interventional Patient Satisfaction Preoperative Anxiety Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: comprehensive educational program for reduction of Pre-Operative Anxiety.
Who it may be relevant to
Registry conditions: Patient Satisfaction, Preoperative Anxiety, Anxiety. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Other comprehensive educational program for reduction of Pre-Operative Anxiety
    BSEP 1 makes use of modern media and aims to educate patients and their carers through educational videos comprising of various aspect of surgical treatment. 1. Introduction to surgery by consultant surgeon, Patient to receive video of their own surgeon. 2. Introduction to Anesthesia. 3. What are different type of breast surgeries in cancer patients (General Video) 4. Specific video pertaining to the type of surgery patient is undergoing (Mastectomy, Breast Conserving Surgery, Breast Re Constru

Primary outcome measures

  • Patient Pre-Operative Anxiety [Time frame: 6 months]
Secondary outcome measures (1)
  • Patient Satisfaction. [Time frame: 6 Months]

Eligibility criteria

Inclusion criteria

  • 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.
  • Females.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Pakistan · 1 center
  • Shaukat Khanum memorial cancer hospital and research centre — Lahore

Identifiers

NCT: NCT05887856 · IRB-22-40

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗