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

NCT03574155 | Unknown DMC

• 1 other identifier: 81886517000005437
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety Disorders

Keywords

Gynecological cancer; Anxiety; Pre-operative counseling

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control- group

NO INTERVENTION

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 Group

EXPERIMENTAL

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

Interventions

Pre-operative Counseling and Education BEHAVIORAL

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.

Also known as: Application of the questionnaire (ESAS) and (HADS)

Experimental Group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Barretos Cancer Hospital: lead

Study Sites (1)

Ricardo Reis

Barretos, São Paulo, Brazil

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Educational Status; 4-amino-4'-hydroxylaminodiphenylsulfone

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Group control Pre-operative Orientation Routine Application of the questionnaire (ESAS) and (HADS) Experimental Group Pre-operative Counseling and Education Application of the questionnaire (ESAS) and (HADS)

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 29, 2018
• Study Start: August 15, 2018
• Primary Completion: December 30, 2018
• Study Completion: August 15, 2019
• Last Updated: January 15, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)