Anxiety Levels Before Hemodialysis Catheter Insertion

Determination of Anxiety Levels After Verbal and Video Informing of Hemodialysis Patients Before Hemodialysis Catheter Insertion

Determination of anxiety levels after verbal and video informing before hemodialysis catheter insertion

Study Overview

• Status: Unknown
• Conditions: Anxiety Levels
• Intervention / Treatment: Procedure: hemodialysis catheter insertion

Detailed Description

Treatment options for end-stage renal patients are renal transplantation, peritoneal dialysis, or hemodialysis, and the majority of these patients live on hemodialysis dependent. The venous access route required for hemodialysis is provided by dialysis catheters until arterio-venous shunts are performed. The aim of this study was to determine the difference between verbal or video-related anxiety levels of patients with hemodialysis and determine which one is better before the hemodialysis procedure is performed.

• Study Type: Observational
• Enrollment (Anticipated): 84

Contacts and Locations

• Study Contact: Name: Hüseyin Mutlu, MD; Phone Number: +905053493263; Email: hmutlu70@hotmail.com
• Study Contact Backup: Name: Ekrem Taha Sert, MD; Phone Number: +905442921495; Email: tahaekrem@hotmail.com

Study Locations

• Turkey
  • Aksaray, Turkey, 68100
    • Recruiting
    • Aksaray Universty
    • Contact: Hüseyin Mutlu, MD; Phone Number: +0905053493263; Email: hmutlu70@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study was planned to receive 84 people. The people to be recruited will be divided into groups.

1. the group will only be informed verbally.
2. The group will be informed as both verbal and video. State-Trait Anxiety Inventory and VAS score will be made after informing all groups and after Hemodialysis Catheter Insertion

Description

Inclusion Criteria:

• Between the ages of 18 -65
• Agree to participate ın the study
• No need for emergency hemodialysis
• No previously known psychiatric disorder
• No history of hemodialysis before
• No history of surgical procedures

Exclusion Criteria:

• Refusing to participate ın the study
• <18 years of age and >65 years
• Need emergency dialysis
• The presence of previously known psychiatric disorder
• Presence of dialysis and catheter
• Presence of a history of surgical procedure
• Lack of information and documents

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
verbal group; The State-Trait Anxiety Inventory (STAI) and Visual Analogue Scale (VAS) levels after verbal informing before hemodialysis catheter insertion	Procedure: hemodialysis catheter insertion; The State-Trait Anxiety Inventory (STAI) and Visual Analogue Scale (VAS) scoring will be performed after informing all groups and after the procedure
verbal and video group; The State-Trait Anxiety Inventory (STAI) and Visual Analogue Scale (VAS) levels after verbal and video informing before hemodialysis catheter insertion	Procedure: hemodialysis catheter insertion; The State-Trait Anxiety Inventory (STAI) and Visual Analogue Scale (VAS) scoring will be performed after informing all groups and after the procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The State-Trait Anxiety Inventory (STAI) and Visual Analogue Scale (VAS) levels	The State-Trait Anxiety Inventory (STAI):To measure via self-report the presence and severity of current symptoms of anxiety and a generalized propensity to be anxious. The STAI has 40 items, 20 items allocated to each of the S-Anxiety and T-Anxiety subscales. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the S-Anxiety scale Visual Analogue Scale (VAS): The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations. Using a ruler, the score is determined by mea-surging the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)	10 minute

Collaborators and Investigators

• Sponsor: Aksaray University Training and Research Hospital
• Investigators: Study Director: Hüseyin Mutlu, MD, Aksaray/Turkey

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2018
• Primary Completion (Anticipated): June 27, 2019
• Study Completion (Anticipated): August 27, 2019

Study Registration Dates

• First Submitted: May 10, 2019
• First Submitted That Met QC Criteria: May 13, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): May 20, 2019
• Last Update Submitted That Met QC Criteria: May 16, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 587943

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