Anxiety Levels Before Hemodialysis Catheter Insertion

NCT03951129 | Unknown

• 1 other identifier: 587943
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anxiety Levels

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

hemodialysis catheter insertion PROCEDURE

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; verbal group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aksaray University Training and Research Hospital: lead

Study Sites (1)

Aksaray Universty

Aksaray, 68100, Turkey (Türkiye)

RECRUITING

Study Officials

• Hüseyin Mutlu, MD

  Aksaray/Turkey

  STUDY DIRECTOR

Central Study Contacts

Hüseyin Mutlu, MD

CONTACT

+905053493263; hmutlu70@hotmail.com

Ekrem Taha Sert, MD

CONTACT

+905442921495; tahaekrem@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Dr. Principal Investigator

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 15, 2019
• Study Start: November 27, 2018
• Primary Completion: June 27, 2019
• Study Completion: August 27, 2019
• Last Updated: May 20, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)