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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04082845
Other study ID # Nurse_thyro01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 10, 2018
Est. completion date May 30, 2019

Study information

Verified date September 2019
Source Karadeniz Technical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date May 30, 2019
Est. primary completion date January 29, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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,

- had total bilateral thyroidectomy,

- had internet connection at home or phone and

- had computer tablet or smartphone.

Exclusion Criteria:

- are mentally handicapped,

- are visual, hearing and speech impaired and

- had psychiatric illness

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Education
Web-based patient education

Locations

Country Name City State
Turkey Bahar Candas Altinbas Trabzon

Sponsors (1)

Lead Sponsor Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 9 days
Primary 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. 2 days
Primary 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. 2 days
Primary 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. 2 days
Primary 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. 2 days
Primary 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 2 days
Primary 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 2 days
Primary 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 2 days
Primary 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. 2 days
Primary 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. 9 days
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