Post-dialysis Recovery Time and Affecting Factors Between Turkey and Portugal

NCT04667741 | Completed

• 1 other identifier: 12869
• Study Type: observational
• Target: 294
• Locations: 1 country
• Sites: 1

Brief Summary

Patients undergoing hemodialysis (HD) can experience symptoms such as lassitude, pain, muscle cramps, nausea, vomiting, constipation, diarrhea, rash, skin dryness, sleep disorders, and emotional and sexual problems after the treatment.

Conditions

Dialysis; Recovery Time

Outcome Measures

Primary Outcomes (8)

• Post-dialysis Recovery Time

  Before the hemodialysis session, the patients were asked by the investigators how long it took them to recover from a dialysis session, taking the last treatment month into account.

  up to 4 weeks

• Anxiety at one month

  It will be assessed with Hospital Anxiety and Depression Scale. This scale, which has a two-factor structure is comprised of 14 items. Seven of these items assess the anxiety status and the remaining seven assess depression. Each item is scored on a four-point scale. Total score ranges between 0 and 21 for anxiety and depression. Scores between 0 and 7 indicate normal emotional status.

  up to 4 weeks

• Depression at one month

  It will be assessed with Hospital Anxiety and Depression Scale. This scale, which has a two-factor structure is comprised of 14 items. Seven of these items assess the anxiety status and the remaining seven assess depression. Each item is scored on a four-point scale. Total score ranges between 0 and 21 for anxiety and depression. Scores between 0 and 7 indicate normal emotional status.

  up to 4 weeks

• Rate of Headache at one month

  The patients will tell the living of headache to the investigators at the end of the one month. The answer will be "yes" or "no".

  up to 4 weeks

• Rate of dry mouth at one month

  The patients will tell the living of dry mouth to the investigators at the end of the one month. The answer will be "yes" or "no".

  up to 4 weeks

• Rate of trouble falling asleep at one month

  The patients will tell the living of trouble falling asleep to the investigators at the end of the one month. The answer will be "yes" or "no".

  up to 4 weeks

• Hemodialysis Sessions Features

  Before and after the hemodialysis sessions, the patients were asked by investigators about dialysate bicarbonate concentration in mmol/L

  up to 4 weeks

• Biochemical variables at one month

  After one month urea reduction rate (%) were aken from the patients' medical record

  up to 4 weeks

Interventions

Post-dialysis recovery group OTHER

Before the hemodialysis session, the patients were asked by the investigators how long it took them to recover from a dialysis session, taking the last treatment month into account.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Being on HD for 4 hours a day on 3 days per week for at least 6 months and 18 years or older in turkey and Portugal

You may qualify if:

• years or older
• Being on HD for 4 hours a day on 3 days per week for at least 6 months
• No communication problem
• Volunteering to participate to the study

You may not qualify if:

• Younger than 18 years
• Shorter being on HD for 4 hours a day on 3 days per week for at least 6 months
• Have communication problem
• Not volunteering to participate to the study

Sponsors & Collaborators

• Istanbul Demiroglu Bilim University: lead

Study Sites (1)

Demiroglu Bilim University

Istanbul, 34384, Turkey (Türkiye)

Location

Related Publications (4)

• Umeukeje EM, Cavanaugh KL. Intradialytic Symptoms and Recovery Time: Thinking 'Outside the Box' to Improve Patients' Dialysis Experience. Kidney Med. 2020 Feb 28;2(2):98-101. doi: 10.1016/j.xkme.2020.02.001. eCollection 2020 Mar-Apr. No abstract available.

  PMID: 32734955 BACKGROUND

• Alvarez L, Brown D, Hu D, Chertow GM, Vassalotti JA, Prichard S. Intradialytic Symptoms and Recovery Time in Patients on Thrice-Weekly In-Center Hemodialysis: A Cross-sectional Online Survey. Kidney Med. 2019 Dec 20;2(2):125-130. doi: 10.1016/j.xkme.2019.10.010. eCollection 2020 Mar-Apr.

  PMID: 32734233 BACKGROUND

• Bossola M, Di Stasio E, Monteburini T, Parodi E, Ippoliti F, Cenerelli S, Santarelli S, Nebiolo PE, Sirolli V, Bonomini M, Antocicco M, Zuccala G, Laudisio A. Recovery Time after Hemodialysis Is Inversely Associated with the Ultrafiltration Rate. Blood Purif. 2019;47(1-3):45-51. doi: 10.1159/000492919. Epub 2018 Sep 19.

  PMID: 30231240 BACKGROUND

• Ozen N, Eyileten T, Teles P, Seloglu B, Gurel A, Ocuk A, Ozen V, Fernandes F, Campos L, Coutinho S, Teixeira J, Moura SCM, Ribeiro O, Sousa CN. Impact of variables on recovery time in patients undergoing hemodialysis: an international survey. BMC Nephrol. 2025 Jan 8;26(1):13. doi: 10.1186/s12882-024-03937-9.

  PMID: 39780078 DERIVED

Study Officials

• Nurten Ozen, Assoc. Prof.

  Istanbul Demiroglu Bilim University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 16, 2020
• Study Start: October 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: July 1, 2022
• Last Updated: September 9, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)