NCT06055426

Brief Summary

The research showed that bed bath applied to palliative care patients in Eskişehir City Hospital Palliative Care Service; It was planned as a randomized experimental study with a pretest-posttest control group design to determine its effect on saturation, pain level and sleep quality.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

1.1 years

First QC Date

September 11, 2023

Last Update Submit

February 5, 2024

Conditions

Keywords

Palliative carenursing carepainsleep qualitybed bathsaturation level

Outcome Measures

Primary Outcomes (3)

  • H1: Bed bath applied to palliative care patients has a saturation regulating effect

    A form was prepared by the researcher. Partial oxygen saturation levels of the patients before, during and after the bath will be measured with the devices (pulse oximeter) used in the clinic where the research will be conducted and recorded on this form.

    1 weeks

  • H3: Bed bath applied to palliative care patients has an effect on the patients' sleep quality.

    The scale developed by Richards in 1987; It is a scale consisting of 6 items that evaluates the depth of night sleep, the time it takes to fall asleep, the frequency of waking up, the time spent awake when waking up, the quality of sleep and the noise level in the environment. The validity and reliability of the scale in our country was conducted by Karaman Özlü and Özer in 2015. It will be measured using the Richard-Campbell Sleep Scale. The scale consists of 6 items that evaluate the depth of night sleep, the time it takes to fall asleep, the frequency of waking up, the time spent awake when waking up, the quality of sleep and the noise level in the environment. It is evaluated on a chart between 0 and 100 using the visual analog scale technique. A score between "0-25" from the scale indicates very poor sleep, and a score between "76-100" indicates very good sleep.quality of patients.

    1 weeks

  • H2: Bed bath applied to palliative care patients has an effect on changing the pain level of the patients.

    Pain will be measured with the Wong-Baker Facial Pain Scale. It was developed by Wong and Baker in 1988. It is a practical and valid measurement tool for the evaluation of cancer-related pain. Patients' pain levels are evaluated by counting their facial expressions. In this scoring, which is done by numbering facial expressions, as the number value increases, the facial expression changes, which indicates an increase in the level of pain. 0-No pain, 2-The pain is very little, 4-The pain is a little more, 6-The pain is even greater, 8-The pain is quite intense, 10-pain means the worst level of pain (Wong and Baker, 1988).

    1 weeks

Study Arms (1)

bed bath

EXPERIMENTAL

Bed bath application stages: * Environmental elements (ambient temperature, airflow and curtain-screen) are taken under control in the clinic (Ensure that the ambient temperature is 23-24℃).

Other: bed bath application

Interventions

Patients who agree to participate in the research and are assigned to the experimental group will receive a bed bath. In order to examine the short-term, medium-term and long-term effects of bed bath, it is planned to have the whole body bed bath performed by the researcher nurse xx three times a week, two days apart.

bed bath

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The first degree relative who voluntarily accepted to participate in the research gave consent to participate in the research,
  • years and older,
  • Receiving inpatient treatment and care in the palliative care service,
  • Patients who do not have bed bath application restrictions will be included.

You may not qualify if:

  • Those who do not voluntarily agree to participate in the research,
  • Under 18 years of age,
  • Not receiving inpatient treatment and care in the palliative care service,
  • Patients who are restricted from using bed baths will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sevil PAMUK CEBECİ

Eskişehir, Odunpazarı, 26020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Mihraç Topçu

    mihrac.topcu1@gmail.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst.Prof.Dr.

Study Record Dates

First Submitted

September 11, 2023

First Posted

September 26, 2023

Study Start

November 10, 2022

Primary Completion

December 30, 2023

Study Completion

January 30, 2024

Last Updated

February 6, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations