HysterectomyNCT05436691
The Effect of Information and Coping With Anxiety Training Given to Women Before Hysterectomy on Their Level of Anxiety
A study testing Information and Coping with Anxiety Training in people with Hysterectomy and Anxiety, run by Mersin Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Purpose: In this study, it was aimed to determine the effect of information and coping with anxiety training given to women before they undergo hysterectomy on their anxiety levels. Design and Methods: The parallel group post-test randomized controlled experimental design was used in the study. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Hysterectomy, Anxiety
- What is being tested?
- Information and Coping with Anxiety Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2018to 15 Dec 2018
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- agreeing to participate in the study,
- being able to speak and understand Turkish,
- being in the age group of 18-65 years,
- being admitted to the aforementioned clinic with a planned hysterectomy surgery,
- not having any health problems preventing the person from hearing and speaking,
- being conscious, being oriented and cooperated,
- not having received any training on hysterectomy before the surgery and during discharge.
Who cannot join
- not agreeing to participate in the study,
- not being able to speak and understand Turkish,
- being under the age group of 18 years,
- not being admitted to the aforementioned clinic with a planned hysterectomy surgery,
- having any health problems preventing the person from hearing and speaking,
- not being conscious, being oriented and cooperated,
- having received any training on hysterectomy before the surgery and during discharge.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Information and Coping With Anxiety Training Given to Women Before Hysterectomy on Their Level of Anxiety: A Post-Test Randomized Controlled Experimental Study
Purpose: In this study, it was aimed to determine the effect of information and coping with anxiety training given to women before they undergo hysterectomy on their anxiety levels.
Design and Methods: The parallel group post-test randomized controlled experimental design was used in the study. The study sample comprised 59 women.
- Conditions
- Hysterectomy, Anxiety
- Being tested
- Information and Coping with Anxiety Training
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information and Coping with Anxiety TrainingOther
Informing and Coping with Anxiety Training was given to the experimental group before the operation through a prepared booklet.The information booklet about the training was created by the researchers by reviewing the current literature. The booklet provides information for patients scheduled for hysterectomy about how to cope with surgery-related anxiety. The booklet provides information on what the hysterectomy is, why it is performed, what risks it has, what should be done before, during and after the hysterectomy, what rules the patient should comply with after hysterectomy, in which cases she should present to the health institution, what changes she might experience in her social, physical, sexual and emotional life after the surgery. The booklet also provides information about discharge training and coping with anxiety.
| Study group | Role | What they receive |
|---|---|---|
| Information and Coping with Anxiety Training Intervention | Experimental | The intervention group received information and coping with anxiety training by an instructor. Receives: Other: Information and Coping with Anxiety Training |
| Control | No intervention | No intervention was applied to the control group.Data were collected from the control group simultaneously with the study group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety was assessed using the State-Trait Anxiety Scale.
The total score obtained from both scales varies between 20 and 80. It states that 0-19 points mean no anxiety, 20-39 points mean mild, 40-59 points mean moderate, 60-79 points mean severe anxiety, and individuals with a score of 60 and above need professional help
Measured: preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start15 Jul 2018
- Primary completion15 Dec 2018
- Study completion15 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies 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
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Elcin Alacam, Mersin Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436691
- Sponsor's protocol ID
- MersinCity
- Status last verified
- Mar 2024
- First submitted
- 22 Jun 2022
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Information and Coping With Anxiety Training Given to Women Before Hysterectomy on Their Level of Anxiety: A Post-Test Randomized Controlled Experimental Study
- ClinicalTrials.gov ID
- NCT05436691
- Acronym / sponsor ID
- MersinCity
- Conditions
- Hysterectomy, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Mersin Training and Research HospitalOther government
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 29 Jun 2022 (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.
Purpose: In this study, it was aimed to determine the effect of information and coping with anxiety training given to women before they undergo hysterectomy on their anxiety levels.
Design and Methods: The parallel group post-test randomized controlled experimental design was used in the study. The study sample comprised 59 women.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Information and Coping with Anxiety Training Intervention | Experimental | Other: Information and Coping with Anxiety TrainingThe intervention group received information and coping with anxiety training by an instructor. |
| Control | No intervention | –No intervention was applied to the control group.Data were collected from the control group simultaneously with the study group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- agreeing to participate in the study,
- being able to speak and understand Turkish,
- being in the age group of 18-65 years,
- being admitted to the aforementioned clinic with a planned hysterectomy surgery,
- not having any health problems preventing the person from hearing and speaking,
Key exclusion criteria (7 listed)
- not agreeing to participate in the study,
- not being able to speak and understand Turkish,
- being under the age group of 18 years,
- not being admitted to the aforementioned clinic with a planned hysterectomy surgery,
- having any health problems preventing the person from hearing and speaking,
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 |
|---|---|---|
| Information and Coping with Anxiety TrainingInforming and Coping with Anxiety Training was given to the experimental group before the operation through a prepared booklet.The information booklet about the training was created by the researchers by reviewing the current literature. The booklet provides information for patients scheduled for hysterectomy about how to cope with surgery-related anxiety. The booklet provides information on what the hysterectomy is, why it is performed, what risks it has, what should be done before, during and after the hysterectomy, what rules the patient should comply with after hysterectomy, in which cases she should present to the health institution, what changes she might experience in her social, physical, sexual and emotional life after the surgery. The booklet also provides information about discharge training and coping with anxiety. | Other | Information and Coping with Anxiety Training Intervention |
Primary outcome
Anxiety was assessed using the State-Trait Anxiety Scale.
Time frame: preoperative
The total score obtained from both scales varies between 20 and 80. It states that 0-19 points mean no anxiety, 20-39 points mean mild, 40-59 points mean moderate, 60-79 points mean severe anxiety, and individuals with a score of 60 and above need professional help
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 21 Mar 2024.
- 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 Information and Coping with Anxiety Training in people with Hysterectomy and Anxiety, run by Mersin Training and Research Hospital 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 7 inclusion and 7 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 21 Mar 2024. 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 was assessed using the State-Trait Anxiety Scale. (time frame: preoperative). 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 21 Mar 2024.