Anxiety DisordersNCT03574155
Impact of Preoperative Counseling and Education in Reducing Anxiety Levels in Patients With Gynecologic Tumors
A study testing Pre-operative Counseling and Education in people with Anxiety Disorders, run by Barretos Cancer Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Pre-operative Counseling and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Aug 2018to 15 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety Disorders
- Being tested
- Pre-operative Counseling and Education
- Keywords
- Gynecological cancer, Anxiety, Pre-operative counseling
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-operative Counseling and EducationBehavioural
Also called Application of the questionnaire (ESAS) and (HADS)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Behavioral: Pre-operative Counseling and Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start15 Aug 2018
- Primary completion30 Dec 2018
- Study completion15 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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)
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo dos Reis, Barretos Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574155
- Sponsor's protocol ID
- 81886517000005437
- Status last verified
- Jan 2019
- First submitted
- 5 Jun 2018
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preoperative Counseling and Education in Reducing Anxiety Levels in Patients With Gynecologic Tumors: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT03574155
- Acronym / sponsor ID
- 81886517000005437
- Conditions
- Anxiety Disorders
- Keywords
- Gynecological cancer, Anxiety, Pre-operative counseling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 15 Aug 2019 (estimated)
- First posted
- 29 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Pre-operative Counseling and EducationComposed 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) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-operative Counseling and EducationAlso: Application of the questionnaire (ESAS) and (HADS)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. | Behavioural | Experimental Group |
Primary outcome
Anxiety levels
Time frame: up to 2 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-operative Counseling and Education in people with Anxiety Disorders, run by Barretos Cancer Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety levels (time frame: up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.