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Completed

NCT Number: NCT04667741

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

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.

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Key information

Conditions

Dialysis Recovery Time

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Demiroglu Bilim University

Istanbul, 34384, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Post-dialysis Recovery Time

    Time frame: 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.

  2. Anxiety at one month

    Time frame: 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.

  3. Depression at one month

    Time frame: 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.

  4. Rate of Headache at one month

    Time frame: 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".

  5. Rate of dry mouth at one month

    Time frame: 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".

  6. Rate of trouble falling asleep at one month

    Time frame: 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".

  7. Hemodialysis Sessions Features

    Time frame: up to 4 weeks

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

  8. Biochemical variables at one month

    Time frame: up to 4 weeks

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

Sponsors and collaborators

Lead sponsor

Istanbul Demiroglu Bilim University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 16, 2020
Registry last updated
Sep 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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