NCT04082845

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 9, 2019

Completed
Last Updated

September 10, 2019

Status Verified

September 1, 2019

Enrollment Period

5 months

First QC Date

August 30, 2019

Last Update Submit

September 7, 2019

Conditions

Outcome Measures

Primary Outcomes (10)

  • 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

Study Arms (2)

Experimental Group

EXPERIMENTAL

The experimental group will be educated via a website that was created by the researchers.

Other: Education

Control Group

NO INTERVENTION

The control group will take rutin patient care.

Interventions

Web-based patient education

Experimental Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • are mentally handicapped,
  • are visual, hearing and speech impaired and
  • had psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahar Candas Altinbas

Trabzon, 61800, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Bahar Candas Altınbas, PhD

    Karadeniz Technical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Parallel Assessment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

August 30, 2019

First Posted

September 9, 2019

Study Start

September 10, 2018

Primary Completion

January 29, 2019

Study Completion

May 30, 2019

Last Updated

September 10, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations