Effect of Web-Based Training With Thyroidectomy Patients

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.

Study Overview

• Status: Completed
• Conditions: Education; General Surgery; Thyroidectomy; Patient
• Intervention / Treatment: Other: Education

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Trabzon, Turkey, 61800
    • Bahar Candas Altinbas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; The experimental group will be educated via a website that was created by the researchers.	Other: Education; Web-based patient education
No Intervention: Control Group; The control group will take rutin patient care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Karadeniz Technical University
• Investigators: Principal Investigator: Bahar Candas Altınbas, PhD, Karadeniz Technical University

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2018
• Primary Completion (Actual): January 29, 2019
• Study Completion (Actual): May 30, 2019

Study Registration Dates

• First Submitted: August 30, 2019
• First Submitted That Met QC Criteria: September 5, 2019
• First Posted (Actual): September 9, 2019

Study Record Updates

• Last Update Posted (Actual): September 10, 2019
• Last Update Submitted That Met QC Criteria: September 7, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Nurse_thyro01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No