Effect of Web-Based Training With Thyroidectomy Patients

September 7, 2019 updated by: Bahar CANDAS ALTINBAS, Karadeniz Technical University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
9 days
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.
2 days
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.
2 days
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.
2 days
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.
2 days
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
2 days
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
2 days
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
2 days
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.
2 days
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.
9 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karadeniz Technical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bahar Candas Altınbas, PhD, Karadeniz Technical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 29, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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