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Trial Title:
Reduction of Pre-operative Anxiety Using a Specially Designed Educational Program for Breast Cancer Patients Undergoing Surgery: a Randomized Controlled Trial
NCT ID:
NCT05887856
Condition:
Patient Satisfaction
Preoperative Anxiety
Anxiety
Conditions: Official terms:
Anxiety Disorders
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Masking description:
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.
Intervention:
Intervention type:
Other
Intervention name:
comprehensive educational program for reduction of Pre-Operative Anxiety
Description:
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 Construction surgery)
5. Explanation of Methicillin-resistant Staphylococcus aureus Decolonization protocol
6. What to expect on Surgery Day
7. Virtual tour of Holding bay and Operation Room
8. Post-Operative care including wound care, drain management and common post-operative
complications.
Arm group label:
Intervention Group
Other name:
Breast Surgery Education Package 1 (BSEP 1)
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shaukat Khanum memorial cancer hospital and research centre
Address:
City:
Lahore
Zip:
536500
Country:
Pakistan
Start date:
November 1, 2024
Completion date:
October 2025
Lead sponsor:
Agency:
Shaukat Khanum Memorial Cancer Hospital & Research Centre
Agency class:
Other
Source:
Shaukat Khanum Memorial Cancer Hospital & Research Centre
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05887856
