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

A Comparative Study Between Turkey and Portugal: Post-dialysis Recovery Time and Affecting Factors

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.

Study Overview

• Status: Completed
• Conditions: Dialysis; Recovery Time
• Intervention / Treatment: Other: Post-dialysis recovery group

Detailed Description

Many chronic HD patients do not feel well after the treatment sessions and need some time to recover. This recovery time is defined as the time required to recover from the feelings of lassitude and fatigue. The patients are limited in their daily living activities at home and at work during this period and a significant amount of time is therefore required to go back to normal life.

• Study Type: Observational
• Enrollment (Actual): 294

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34384
    • Demiroglu Bilim University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

• 18 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Istanbul Demiroglu Bilim University
• Investigators: Study Director: Nurten Ozen, Assoc. Prof., Istanbul Demiroglu Bilim University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: December 8, 2020
• First Posted (Actual): December 16, 2020

Study Record Updates

• Last Update Posted (Actual): September 9, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 12869

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