Adnexal MassNCT04260334
Preoperative Care In Ovarian Cancer Patients
A study testing Preoperative Education in people with Adnexal Mass and Perioperative Complication, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
A randomised controlled trial study consisting of two-group pretest-post-test. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Adnexal Mass, Perioperative Complication, Outcome, Fatal
- What is being tested?
- Preoperative Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Nov 2019to 30 Sep 2020
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and over
- women who know diagnosis
- women who have not psychiatric illness
- women who have preoperative period
- hospitalization two days before surgery
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Science University Tepecik Education and Research Hospital
Izmir, 35100
About this study
Official title: Preoperative Care in Ovarian Cancer: Effects of Relaxation-Focused Nursing Program in Women With Ovarian Cancer
A randomised controlled trial study consisting of two-group pretest-post-test.
Read the detailed description
This study was designed as a randomized controlled trial with pretest and posttest model. The sample of the research consisted of patients who would undergo ovarian cancer surgery at the gynecologic oncology unit of a university hospital in Turkey between June 2019-August 2020.
The women were randomly assigned using "a random number generation program (Research Randomizer (https://www.randomizer.org/)" by an independent researcher who was not included in the study, intervention and control groups were formed. Women were not informed about the group they would be a part of. However, the groups of women were known by the researchers.
- Conditions
- Adnexal Mass, Perioperative Complication, Outcome, Fatal
- Being tested
- Preoperative Education
- Keywords
- Adnexal mass, Preoperative education, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative EducationOther
The first two hours after the hospitalization of the patient will be met and the aim of the study will be explained. On the same day, the patient will be given breathing and relaxation exercises and explained why it is important. On the second day after the hospitalization, the patient will be evaluated and the previous day's exercises will be repeated and leg exercises will be performed. The importance of mobilization will then be highlighted. the same day gradual relaxation exercise and surgical relaxation will be administered to the patient three times. The patient will be evaluated on the first postoperative day.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | RFNP was created by researchers. RFNP comprises positive language, a positive environment, relaxation exercise and methods of coping with stress (Mete et al., 2017; Mete et al., 2015; Lazarus, 1984). This programme has a content which reducing women's anxiety and pain. Such programmes are expected to enhanced level of the knowledge about ovarian cancer and its surgery. Women are usually admitted to the clinic two days before surgery. The program duration was for 2 days each day with two sessions, of 6 hr each. There are four relaxation exercises in the program because repetition is recommended for the relaxation exercises to be effective. Deep breathing exercise, progressive muscle relaxation, and guided imagery were used in program. In addition, RFNP is divided into four sections so that the information is not intensely transferred to women. Receives: Other: Preoperative Education |
| Control Group | No intervention | In the control group, women received routine nursing care in the hospital, and data collection tools were applied at the parallel hours as the experimental group. Usual nursing care included information about visitor and meal times, nurse call button, diet, drug administration and not to leave the hospital. Relaxation exercises were not practiced to patients in usual nursing care to reduce stress and anxiety. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
It has been measured The State and Trait Anxiety Inventory. Form Y, its most popular version, has 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Scores range from 20 to 80, with higher scores correlating with greater anxiety.
Measured: 3 days
analgesia
It has been measured visual analog scale for pain. Scores range from 0 to 10, with higher scores correlating with greater pain.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start11 Nov 2019
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adnexal MassStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buse Güler, Dokuz Eylul University
- Investigators
- Buse Güler, MSc, Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260334
- Sponsor's protocol ID
- 2019/06-42
- Status last verified
- Apr 2022
- First submitted
- 6 Nov 2019
- Last updated
- 29 Apr 2022
- 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 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Care in Ovarian Cancer: Effects of Relaxation-Focused Nursing Program in Women With Ovarian Cancer
- ClinicalTrials.gov ID
- NCT04260334
- Acronym / sponsor ID
- 2019/06-42
- Conditions
- Adnexal Mass, Perioperative Complication, Outcome, Fatal
- Keywords
- Adnexal mass, Preoperative education, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 7 Feb 2020 (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.
A randomised controlled trial study consisting of two-group pretest-post-test.
Detailed description
This study was designed as a randomized controlled trial with pretest and posttest model. The sample of the research consisted of patients who would undergo ovarian cancer surgery at the gynecologic oncology unit of a university hospital in Turkey between June 2019-August 2020.
The women were randomly assigned using "a random number generation program (Research Randomizer (https://www.randomizer.org/)" by an independent researcher who was not included in the study, intervention and control groups were formed. Women were not informed about the group they would be a part of. However, the groups of women were known by the researchers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Preoperative EducationRFNP was created by researchers. RFNP comprises positive language, a positive environment, relaxation exercise and methods of coping with stress (Mete et al., 2017; Mete et al., 2015; Lazarus, 1984). This programme has a content which reducing women's anxiety and pain. Such programmes are expected to enhanced level of the knowledge about ovarian cancer and its surgery. Women are usually admitted to the clinic two days before surgery. The program duration was for 2 days each day with two sessions, of 6 hr each. There are four relaxation exercises in the program because repetition is recommended for the relaxation exercises to be effective. Deep breathing exercise, progressive muscle relaxation, and guided imagery were used in program. In addition, RFNP is divided into four sections so that the information is not intensely transferred to women. |
| Control Group | No intervention | –In the control group, women received routine nursing care in the hospital, and data collection tools were applied at the parallel hours as the experimental group. Usual nursing care included information about visitor and meal times, nurse call button, diet, drug administration and not to leave the hospital. Relaxation exercises were not practiced to patients in usual nursing care to reduce stress and anxiety. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years and over
- women who know diagnosis
- women who have not psychiatric illness
- women who have preoperative period
- hospitalization two days before surgery
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Preoperative EducationThe first two hours after the hospitalization of the patient will be met and the aim of the study will be explained. On the same day, the patient will be given breathing and relaxation exercises and explained why it is important. On the second day after the hospitalization, the patient will be evaluated and the previous day's exercises will be repeated and leg exercises will be performed. The importance of mobilization will then be highlighted. the same day gradual relaxation exercise and surgical relaxation will be administered to the patient three times. The patient will be evaluated on the first postoperative day. | Other | Intervention Group |
Primary outcome
Anxiety
Time frame: 3 days
It has been measured The State and Trait Anxiety Inventory. Form Y, its most popular version, has 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Scores range from 20 to 80, with higher scores correlating with greater anxiety.
analgesia
Time frame: 3 days
It has been measured visual analog scale for pain. Scores range from 0 to 10, with higher scores correlating with greater pain.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- 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.
Buse Güler, MSc principal investigator
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Education in people with Adnexal Mass and Perioperative Complication, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 29 Apr 2022. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: 3 days). The study lists 2 primary outcomes in all. 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 29 Apr 2022.