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

Completed

• Conditions: Dialysis; Recovery Time

• Registration Number: NCT04667741
• Lead Sponsor: Istanbul Demiroglu Bilim University

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.

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 Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2020-12-08
• Study First Submitted QC: 2020-12-08
• Study First Posted: 2020-12-16
• Primary Completion: 2022-04-01
• Study Completion: 2022-07-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-08
• Last Update Posted: 2022-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 294

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-dialysis Recovery Time	up to 4 weeks	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.
Rate of trouble falling asleep at one month	up to 4 weeks	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".
Biochemical variables at one month	up to 4 weeks	After one month urea reduction rate (%) were aken from the patients' medical record
Hemodialysis Sessions Features	up to 4 weeks	Before and after the hemodialysis sessions, the patients were asked by investigators about dialysate bicarbonate concentration in mmol/L
Anxiety at one month	up to 4 weeks	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.
Depression at one month	up to 4 weeks	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.
Rate of Headache at one month	up to 4 weeks	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".
Rate of dry mouth at one month	up to 4 weeks	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".

Trial Locations

Locations (1)

Demiroglu Bilim University; 🇹🇷 Istanbul, Turkey