PAUSDE: Reduction of Pre-operative Anxiety Using a Specially Designed Educational Program for Breast Cancer Patients Undergoing Surgery: A Randomized Controlled Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Intervention Group 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. |
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.
Introduction to surgery by consultant surgeon, Patient to receive video of their own surgeon.
Introduction to Anesthesia.
What are different type of breast surgeries in cancer patients (General Video)
Specific video pertaining to the type of surgery patient is undergoing (Mastectomy, Breast Conserving Surgery, Breast Re Construction surgery)
Explanation of Methicillin-resistant Staphylococcus aureus Decolonization protocol
What to expect on Surgery Day
Virtual tour of Holding bay and Operation Room
Post-Operative care including wound care, drain management and common post-operative complications.
Other Names:
|
| No Intervention: Non-Intervention Group Non-Intervention group will get the usual standard information as per existing protocols which includes Explanation of surgical procedure by primary team. Information about anesthesia on pre-operative anesthesia assessment. Phone call from Primary team explaining surgery details one day prior to surgery in case of day case surgery. 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. |
Outcome Measures
Primary Outcome Measures
- Patient Pre-Operative Anxiety [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.
Secondary Outcome Measures
- Patient Satisfaction. [6 Months]
This will be measured using Patient satisfaction questionnaire Short Form (PSQ-18). The short-form instrument, the PSQ-18, contains 18 items comprising of General satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, accessibility and convenience. PSQ-18 is a free to use validated tool developed by RAND Corporation. The translation of the tool is allowed by the RAND Corporation with precise instructions regarding the translation process. These instructions were followed while translating the tool. 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 to 70 years of age.
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Known cases of Breast Cancer.
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Undergoing Breast Surgery as a part of treatment.
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Availability of Personal smart phone at home.
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Written informed Consent given for participation in trial.
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Females.
Exclusion Criteria:
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Less than 18 years or more than 70 years of age.
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Stage IV patients undergoing palliative breast surgery.
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Patient having chronic pain.
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Un-availability of smart phone.
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Patients with known psychiatric/depression disorders.
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Previous history of another treated carcinoma.
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Patients with re-current breast carcinoma.
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Male Patients are excluded from study.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Shaukat Khanum Memorial Cancer Hospital & Research Centre
Investigators
- Principal Investigator: Dr. Barka Sajjad, M.B.B.S, FCPS, MRCS, Shaukat Khanum memorial cancer hospital and research centre lahore
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Ahlberg K, Ekman T, Wallgren A, Gaston-Johansson F. Fatigue, psychological distress, coping and quality of life in patients with uterine cancer. J Adv Nurs. 2004 Jan;45(2):205-13. doi: 10.1046/j.1365-2648.2003.02882.x.
- Aviado-Langer J. Measuring preoperative anxiety in patients with breast cancer using the visual analog scale. Clin J Oncol Nurs. 2014 Oct;18(5):489-91. doi: 10.1188/14.CJON.489-491.
- Badner NH, Nielson WR, Munk S, Kwiatkowska C, Gelb AW. Preoperative anxiety: detection and contributing factors. Can J Anaesth. 1990 May;37(4 Pt 1):444-7. doi: 10.1007/BF03005624.
- Boeke S, Duivenvoorden HJ, Verhage F, Zwaveling A. Prediction of postoperative pain and duration of hospitalization using two anxiety measures. Pain. 1991 Jun;45(3):293-297. doi: 10.1016/0304-3959(91)90053-Z.
- Granziera E, Guglieri I, Del Bianco P, Capovilla E, Dona' B, Ciccarese AA, Kilmartin D, Manfredi V, De Salvo GL. A multidisciplinary approach to improve preoperative understanding and reduce anxiety: a randomised study. Eur J Anaesthesiol. 2013 Dec;30(12):734-42. doi: 10.1097/EJA.0b013e3283652c0c.
- Takahashi T, Hondo M, Nishimura K, Kitani A, Yamano T, Yanagita H, Osada H, Shinbo M, Honda N. Evaluation of quality of life and psychological response in cancer patients treated with radiotherapy. Radiat Med. 2008 Aug;26(7):396-401. doi: 10.1007/s11604-008-0248-5. Epub 2008 Sep 4.
- Vileikyte L. Stress and wound healing. Clin Dermatol. 2007 Jan-Feb;25(1):49-55. doi: 10.1016/j.clindermatol.2006.09.005.
- Zhang C, Liu X, Hu T, Zhang F, Pan L, Luo Y, Wang Z. Development and psychometric validity of the perioperative anxiety scale-7 (PAS-7). BMC Psychiatry. 2021 Jul 16;21(1):358. doi: 10.1186/s12888-021-03365-1.
- IRB-22-40