ThyroidectomyNCT04082845
Effect of Web-Based Training With Thyroidectomy Patients
A study testing Education in people with Thyroidectomy and Education, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the effect of an internet website, created by the nurse for the purpose of internet-based training related to perioperative period, on the anxiety and postoperative recovery measures (length of hospitalization, first oral feeding time, first mobilization time, first defecation time, first gas… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thyroidectomy, Education, General Surgery
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2018to 30 May 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- older than 18 years and old,
- had planned surgery,
- speaks and understands Turkish,
- are literate,
- learned to have surgery at least one day before surgery,
- had first thyroidectomy,
Show all 9Show fewer
- had total bilateral thyroidectomy,
- had internet connection at home or phone and
- had computer tablet or smartphone.
Who cannot join
- are mentally handicapped,
- are visual, hearing and speech impaired and
- had psychiatric illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Web-Based Training on the Anxiety and Early Recovery Outcomes of Thyroidectomy Patients: Randomized Controlled Study
This study evaluates the effect of an internet website, created by the nurse for the purpose of internet-based training related to perioperative period, on the anxiety and postoperative recovery measures (length of hospitalization, first oral feeding time, first mobilization time, first defecation time, first gas release, pain, nausea, vomiting, re-admission) of thyroidectomy patients. For this, while the experimental group will educate via the internet, the control group will take rutin care.
Read the detailed description
Today, due to changing guidelines, current approaches, and new paradigms, the approach to thyroid surgery has become more sensitive and selective. Besides, thyroid surgery has increased due to the increase in thyroid cancer and early detection of thyroid nodules. In a comprehensive study conducted by the Thyroid Cancer Association with 2398 patients in 35 countries, it is found that 92.6% of the patients did not receive psychological support, 84.1% did not receive institutional information, and 63.0% did not receive written information about the disease or treatment. Thyroidectomy patients are known to experience postoperative complications and symptoms such as hypocalcemia, hoarseness, dysphagia, drowsiness, or restricted neck/shoulder movement. Therefore, informing thyroidectomy patients about the surgical process will facilitate the management of the process. In addition to this, due to the increasing use of the internet with the developing technology, the behaviors of the patients searching for information from the internet are increasing day by day. It has been found that the rate of searching for health information from the internet is 68-72% in the world. Under this scope, this study will evaluate the effect of the web-based training on with thyroidectomy patients
- Conditions
- Thyroidectomy, Education, General Surgery, Patient
- Being tested
- Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
Web-based patient education
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The experimental group will be educated via a website that was created by the researchers. Receives: Other: Education |
| Control Group | No intervention | The control group will take rutin patient care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of patient anxiety
Self reported anxiety intensity during surgical process that includes on the day of surgery and one week after surgery. State-Trait Anxiety Inventory will be used to evaluate the anxiety. The higher the score is the more anxiety.
Measured: 9 days
Rate of length of hospitalization
It means that how long did the patients stay at the hospital during surgery? This measure record via questionnaire as day. The minimum, maximum, median, 25th and 75th quartile were evaluated for each group and compared between the groups.
Measured: 2 days
Rate of first feeding time after surgery
It is described that how many hours after surgery did the patients eat first? This measure record via questionnaire as day. The minimum, maximum, median, 25th and 75th quartile were evaluated for each group and compared between the groups.
Measured: 2 days
Rate of first mobilization time after surgery
How many hours after surgery did the patients walk first? This measure record via questionnaire as day. The minimum, maximum, median, 25th and 75th quartile were evaluated for each group and compared between the groups.
Measured: 2 days
Rate of first defecation time after surgery
How many hours after surgery did the patients deface first? This measure record via questionnaire as day. The minimum, maximum, median, 25th and 75th quartile were evaluated for each group and compared between the groups.
Measured: 2 days
Rate of first gas release time after surgery
How many hours after surgery did the patients release gas first? This measure record via questionnaire as day. The minimum, maximum, median, 25th and 75th quartile were evaluated for each group and compared between the groups
Measured: 2 days
Concentration of pain after surgery
It means that what is the severity of the pain that the patients had in 24 hours after surgery. It evaluated with Visual Analog Scale. The most common style used in pain measurement uses a horizontal line measuring exactly 10 cm. The patient is asked to make a mark on this line (from 0 to 10), then the line is measured and recorded in millimeters or centimeters. The higher the score is the more severe the pain. The severity of the pain compared between groups as average
Measured: 2 days
Concentration of nausea after surgery
It is the severity of the nausea that the patients had in 24 hours after surgery. It evaluated with Visual Analog Scale. The patient is asked to make a mark on the line (from 0 to 10), then the line is measured and recorded in millimeters or centimeters. The higher the score is the more severe the nausea. The severity of the nausea compared between groups as average
Measured: 2 days
Rate of vomiting after surgery until the discharge
It means that how many times did patients vomit until the discharge. It evaluated as number via questionnaire. The minimum, maximum, median, 25th and 75th quartile were evaluated for each group and compared between the groups.
Measured: 2 days
Number of Participants with re-admission after discharge
It shows that how many patients are re-admitted to the hospital in one week after discharge It evaluated as number via questionnaire. The minimum, maximum, median, 25th and 75th quartile were evaluated for each group and compared between the groups.
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start10 Sep 2018
- Primary completion29 Jan 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidectomyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assessment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahar CANDAS ALTINBAS, Karadeniz Technical University
- Investigators
- Bahar Candas Altınbas, PhD, Principal investigator, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082845
- Sponsor's protocol ID
- Nurse_thyro01
- Status last verified
- Sep 2019
- First submitted
- 30 Aug 2019
- Last updated
- 10 Sep 2019
- 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 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Web-Based Training on the Anxiety and Early Recovery Outcomes of Thyroidectomy Patients: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04082845
- Acronym / sponsor ID
- Nurse_thyro01
- Conditions
- Thyroidectomy, Education, General Surgery, Patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 29 Jan 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 9 Sep 2019 (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.
This study evaluates the effect of an internet website, created by the nurse for the purpose of internet-based training related to perioperative period, on the anxiety and postoperative recovery measures (length of hospitalization, first oral feeding time, first mobilization time, first defecation time, first gas release, pain, nausea, vomiting, re-admission) of thyroidectomy patients. For this, while the experimental group will educate via the internet, the control group will take rutin care.
Detailed description
Today, due to changing guidelines, current approaches, and new paradigms, the approach to thyroid surgery has become more sensitive and selective. Besides, thyroid surgery has increased due to the increase in thyroid cancer and early detection of thyroid nodules. In a comprehensive study conducted by the Thyroid Cancer Association with 2398 patients in 35 countries, it is found that 92.6% of the patients did not receive psychological support, 84.1% did not receive institutional information, and 63.0% did not receive written information about the disease or treatment. Thyroidectomy patients are known to experience postoperative complications and symptoms such as hypocalcemia, hoarseness, dysphagia, drowsiness, or restricted neck/shoulder movement. Therefore, informing thyroidectomy patients about the surgical process will facilitate the management of the process. In addition to this, due to the increasing use of the internet with the developing technology, the behaviors of the patients searching for information from the internet are increasing day by day. It has been found that the rate of searching for health information from the internet is 68-72% in the world. Under this scope, this study will evaluate the effect of the web-based training on with thyroidectomy patients
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assessment
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: EducationThe experimental group will be educated via a website that was created by the researchers. |
| Control Group | No intervention | –The control group will take rutin patient care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- older than 18 years and old,
- had planned surgery,
- speaks and understands Turkish,
- are literate,
- learned to have surgery at least one day before surgery,
Key exclusion criteria (3 listed)
- are mentally handicapped,
- are visual, hearing and speech impaired and
- had psychiatric illness
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 |
|---|---|---|
| EducationWeb-based patient education | Other | Experimental Group |
Primary outcome
Concentration of patient anxiety
Time frame: 9 days
Self reported anxiety intensity during surgical process that includes on the day of surgery and one week after surgery. State-Trait Anxiety Inventory will be used to evaluate the anxiety. The higher the score is the more anxiety.
Rate of length of hospitalization
Time frame: 2 days
It means that how long did the patients stay at the hospital during surgery? This measure record via questionnaire as day. The minimum, maximum, median, 25th and 75th quartile were evaluated for each group and compared between the groups.
Rate of first feeding time after surgery
Time frame: 2 days
It is described that how many hours after surgery did the patients eat first? This measure record via questionnaire as day. The minimum, maximum, median, 25th and 75th quartile were evaluated for each group and compared between the groups.
Rate of first mobilization time after surgery
Time frame: 2 days
How many hours after surgery did the patients walk first? This measure record via questionnaire as day. The minimum, maximum, median, 25th and 75th quartile were evaluated for each group and compared between the groups.
Rate of first defecation time after surgery
Time frame: 2 days
How many hours after surgery did the patients deface first? This measure record via questionnaire as day. The minimum, maximum, median, 25th and 75th quartile were evaluated for each group and compared between the groups.
Rate of first gas release time after surgery
Time frame: 2 days
How many hours after surgery did the patients release gas first? This measure record via questionnaire as day. The minimum, maximum, median, 25th and 75th quartile were evaluated for each group and compared between the groups
Concentration of pain after surgery
Time frame: 2 days
It means that what is the severity of the pain that the patients had in 24 hours after surgery. It evaluated with Visual Analog Scale. The most common style used in pain measurement uses a horizontal line measuring exactly 10 cm. The patient is asked to make a mark on this line (from 0 to 10), then the line is measured and recorded in millimeters or centimeters. The higher the score is the more severe the pain. The severity of the pain compared between groups as average
Concentration of nausea after surgery
Time frame: 2 days
It is the severity of the nausea that the patients had in 24 hours after surgery. It evaluated with Visual Analog Scale. The patient is asked to make a mark on the line (from 0 to 10), then the line is measured and recorded in millimeters or centimeters. The higher the score is the more severe the nausea. The severity of the nausea compared between groups as average
Rate of vomiting after surgery until the discharge
Time frame: 2 days
It means that how many times did patients vomit until the discharge. It evaluated as number via questionnaire. The minimum, maximum, median, 25th and 75th quartile were evaluated for each group and compared between the groups.
Number of Participants with re-admission after discharge
Time frame: 9 days
It shows that how many patients are re-admitted to the hospital in one week after discharge It evaluated as number via questionnaire. The minimum, maximum, median, 25th and 75th quartile were evaluated for each group and compared between the groups.
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 10 Sep 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.
Bahar Candas Altınbas, PhD principal investigator
Karadeniz Technical 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 Education in people with Thyroidectomy and Education, run by Karadeniz Technical 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 9 inclusion and 3 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 10 Sep 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 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?
Concentration of patient anxiety (time frame: 9 days). The study lists 10 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 10 Sep 2019.