Impact of Preoperative Counseling and Education in Reducing Anxiety Levels in Patients With Gynecologic Tumors

Impact of Preoperative Counseling and Education in Reducing Anxiety Levels in Patients With Gynecologic Tumors: A Prospective Randomized Study

The surgical procedure can be considered a transition in the patient's life. The transition can generate instability and produce negative effects, which may be temporary or permanent. Failure to prepare people to deal with the unexpected, such as diagnosing a disease, such as cancer, and surgical necessity can be a frightening and frustrating experience, developing painful and distressing feelings, involving their family members as well.

Study Overview

• Status: Unknown
• Conditions: Anxiety Disorders
• Intervention / Treatment: Behavioral: Pre-operative Counseling and Education

Detailed Description

A preoperative orientation process with potential benefits to the patient has been adopted for some surgical procedures. However, recently some surgical specialties such as orthopedics have been implemented in their routine a potentially modifiable conduct of the emotional trauma of a surgery, is the use of the preoperative advice and orientation, in order to attain an ability to increase the client's satisfaction, to facilitate the recovery, decrease the rate of complications without increasing reintegration, decrease hospitalization time and health costs without additional patient risk. There is a belief among surgeons that preoperative counseling and counseling is vitally important for a post-operative outcome. Despite this, there is a paucity of well-conducted studies that examine the importance of the need for preoperative counseling with detailed information to analyze the yearnings and needs as well as the emotional impact. In addition, there are few studies evaluating the emotional impact and impact in the postoperative period in general of detailed preoperative counseling in patients with gynecological tumors submitted to laparotomy and minimally invasive surgery. For these reasons, this study aims to evaluate whether the application of detailed and clear preoperative counseling and education about the surgical procedure to be performed, as well as all the perioperative guidelines that involve the procedure versus the usual preoperative orientation and preoperative, can have an impact on the level of anxiety of the patient and the companion, as well as assess the degree of satisfaction of the companion.

• Study Type: Interventional
• Enrollment (Anticipated): 274
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Barretos, São Paulo, Brazil
      • Ricardo Reis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients submitted to accessory treatment for tumors of the cervix, vulva, ovary or endometrium.
• Primary therapy, which may be radiotherapy or chemotherapy.
• Patients between the ages of 20 and 80 years.
• Patients submitted to a laparotomic or minimally invasive method (robotic and laparoscopic).
• Patients should be treated at the Oncology Gynecology Service of the Barretos Cancer Hospital.

Exclusion Criteria:

• Patients treated at another oncology service previously.
• Patients who have already been treated for some other cancer in the past.
• Patients without a complete primary level and / or who can not read or write.
• Patients and / or family members who refuse to participate in the study.
• Patients who will be admitted to the ICU.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control- group; It is composed of patients scheduled for surgical treatment by tumors of the uterine cervix, vulva, ovary or endometrium, who will receive preoperative and postoperative guidelines according to the usual routine for the perioperative period of the present institution. Patients and their followers of the control group will participate in a preoperative consultation with the surgeon to discuss the indication of the procedure and its risks, benefits and alternatives to the procedure being indicated, if any. Pre-operative Counseling and Education Application of the questionnaire (ESAS) and (HADS)
Experimental: Experimental Group; Composed of patients scheduled for surgical treatment by tumors of the uterine cervix, vulva, ovary or endometrium who will receive preoperative counseling and education through a pre-defined protocol after preoperative consultation with the surgeon. The counseling session will take place with at least one companion. The purpose of this session is to supplement, re-emphasize and strengthen the perioperative guidelines. An illustration (explanatory folder) will be used to demonstrate the location of the surgery, how the scar will be and on which sites of the abdomen and organs the surgery will cover. All this counseling and education will be applied at the same time to the patient and her companion. At the end of the intervention, a space will be left open for both the patient and the companion to ask questions and questions. Pre-operative Counseling and Education Application of the questionnaire (ESAS) and (HADS)	Behavioral: Pre-operative Counseling and Education; Group control Pre-operative Orientation Routine Application of the questionnaire (ESAS) and (HADS) Post-operative Immediate (1 OP) Application of the Questionnaire to assess HADS and ESAS Anxiety (Patient) Experimental Group Pre-operative Counseling and Education Application of the questionnaire (ESAS) and (HADS) Late postoperative (2 - 4 weeks) Questioning the patient and companion evaluating the degree of satisfaction regarding the preoperative guidelines.; Other Names: Application of the questionnaire (ESAS) and (HADS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety levels	The investigators will measure anxiety levels using the Hospital Anxiety and Depression Scale.The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal.	up to 2 months

Collaborators and Investigators

• Sponsor: Barretos Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2018
• Primary Completion (Actual): December 30, 2018
• Study Completion (Anticipated): August 15, 2019

Study Registration Dates

• First Submitted: June 5, 2018
• First Submitted That Met QC Criteria: June 28, 2018
• First Posted (Actual): June 29, 2018

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 14, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Anxiety; Gynecological cancer; Pre-operative counseling
• Additional Relevant MeSH Terms: Mental Disorders; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Anxiety Disorders; Genital Neoplasms, Female
• Other Study ID Numbers: 81886517000005437

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No