Palliative CareNCT06055426
The Effect of Bed Bath Applied to Palliative Care Patients on Saturation, Pain Level and Sleep Quality
A study testing bed bath application in people with Palliative Care, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Palliative Care
- What is being tested?
- bed bath application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Nov 2022to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The first degree relative who voluntarily accepted to participate in the research gave consent to participate in the research,
- 18 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sevil PAMUK CEBECİ
Eskişehir, Odunpazarı, 26020
About this study
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.
Read the detailed description
Considering the individual's comfort and stabilization of vital signs, bathing practice, which is one of the independent roles of nursing; It should be applied with the right method at healthy intervals. Considering the studies on bathing in bed or in the shower; It has been observed that bathing increases patients' oxygen saturation, ensures effective breathing, reduces blood pressure and body temperature, ensures skin integrity, increases patient comfort and quality of life, and reduces anxiety levels (Uğur, 2018). In their study, Downey and Lloyd (2008) emphasize that bed bathing in hospitalized patients is important for personal cleanliness, well-being and preventing the development of infection. According to this study report, the improvement of communication between the nurse and the individual provides nurses with the opportunity to evaluate the daily activities of patient individuals. The nurse evaluates the patients' independence or dependency in activities such as individual hygiene, mobility, excretion and clothing, and thus obtains information about the individual's nutrition, sleep patterns and whether he or she has pain. It is also stated that such communication allows the individual to express his/her opinions about care, treatment or daily practices. In Erçin's (2006) study, in which the effect of early and late period bed bathing on mixed venous oxygen saturation after coronary artery bypass graft application was evaluated, no difference was seen between the control and experimental groups, while it was determined that the mixed venous oxygen saturation of both groups increased during bed bathing.
In the literature; The number of studies on the effects of bed bath application on palliative care patient groups, who frequently experience sleep disturbance and pain, is quite limited. With this study, it is aimed to contribute to the literature.
The universe of the research; It consists of patients hospitalized in the Palliative Care Clinics of a hospital in Eskişehir, Turkey. The sample size was calculated with the G power program based on the effect size obtained from the literature. The observed effect size for the parameters to be measured between groups was calculated as 0.95. According to these results, according to the power analysis calculated with 95% power and 0.05 significance level based on the two-way hypothesis in the experimental and control groups, it was calculated that a total of 60 individuals should participate in the study, at least 21 in the experimental group and 21 in the control group. This analysis was calculated with the G Power program version 3.1.
Research hypotheses
H1: Bed bath applied to palliative care patients has the effect of increasing the saturation level of the patients.
H2: Bed bath applied to palliative care patients has an effect on reducing the pain level of the patients.
H3: Bed bath applied to palliative care patients has an effect on improving the sleep quality of patients.
Randomization Method: Participants will be assigned to the experimental and control groups using the simple randomization method. Patients will be given a number starting from 1 according to the order of admission.
Patients who accepted to participate in the study and were assigned to the experimental group will be given a bed bath. In order to examine the short-term, medium-term and long-term effects of the bath, it is planned to have a whole body bed bath performed by researcher nurse XX three times a week, two days apart.
- Richard-Campbell Sleep Scale, Wong-Baker Facial Pain Scale will be applied and oxygen saturation will be measured before and after bed bath.
- The control group patients will not be given a bed bath, their measurements will be made simultaneously with the experimental group.
- Conditions
- Palliative Care
- Being tested
- bed bath application
- Keywords
- Palliative care, nursing care, pain, sleep quality, bed bath, saturation level
- Medical subject headings
- Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bed bath applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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℃). Receives: Other: bed bath application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start10 Nov 2022
- Primary completion30 Dec 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevil PAMUK CEBECİ, Eskisehir Osmangazi University
- Investigators
- Mihraç Topçu, Principal investigator, mihrac.topcu1@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055426
- Sponsor's protocol ID
- 2023-4
- Status last verified
- Feb 2024
- First submitted
- 11 Sep 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bed Bath Applied to Palliative Care Patients on Saturation, Pain Level and Sleep Quality
- ClinicalTrials.gov ID
- NCT06055426
- Acronym / sponsor ID
- 2023-4
- Conditions
- Palliative Care
- Keywords
- Palliative care, nursing care, pain, sleep quality, bed bath, saturation level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Considering the individual's comfort and stabilization of vital signs, bathing practice, which is one of the independent roles of nursing; It should be applied with the right method at healthy intervals. Considering the studies on bathing in bed or in the shower; It has been observed that bathing increases patients' oxygen saturation, ensures effective breathing, reduces blood pressure and body temperature, ensures skin integrity, increases patient comfort and quality of life, and reduces anxiety levels (Uğur, 2018). In their study, Downey and Lloyd (2008) emphasize that bed bathing in hospitalized patients is important for personal cleanliness, well-being and preventing the development of infection. According to this study report, the improvement of communication between the nurse and the individual provides nurses with the opportunity to evaluate the daily activities of patient individuals. The nurse evaluates the patients' independence or dependency in activities such as individual hygiene, mobility, excretion and clothing, and thus obtains information about the individual's nutrition, sleep patterns and whether he or she has pain. It is also stated that such communication allows the individual to express his/her opinions about care, treatment or daily practices. In Erçin's (2006) study, in which the effect of early and late period bed bathing on mixed venous oxygen saturation after coronary artery bypass graft application was evaluated, no difference was seen between the control and experimental groups, while it was determined that the mixed venous oxygen saturation of both groups increased during bed bathing.
In the literature; The number of studies on the effects of bed bath application on palliative care patient groups, who frequently experience sleep disturbance and pain, is quite limited. With this study, it is aimed to contribute to the literature.
The universe of the research; It consists of patients hospitalized in the Palliative Care Clinics of a hospital in Eskişehir, Turkey. The sample size was calculated with the G power program based on the effect size obtained from the literature. The observed effect size for the parameters to be measured between groups was calculated as 0.95. According to these results, according to the power analysis calculated with 95% power and 0.05 significance level based on the two-way hypothesis in the experimental and control groups, it was calculated that a total of 60 individuals should participate in the study, at least 21 in the experimental group and 21 in the control group. This analysis was calculated with the G Power program version 3.1.
Research hypotheses
H1: Bed bath applied to palliative care patients has the effect of increasing the saturation level of the patients.
H2: Bed bath applied to palliative care patients has an effect on reducing the pain level of the patients.
H3: Bed bath applied to palliative care patients has an effect on improving the sleep quality of patients.
Randomization Method: Participants will be assigned to the experimental and control groups using the simple randomization method. Patients will be given a number starting from 1 according to the order of admission.
Patients who accepted to participate in the study and were assigned to the experimental group will be given a bed bath. In order to examine the short-term, medium-term and long-term effects of the bath, it is planned to have a whole body bed bath performed by researcher nurse XX three times a week, two days apart.
- Richard-Campbell Sleep Scale, Wong-Baker Facial Pain Scale will be applied and oxygen saturation will be measured before and after bed bath.
- The control group patients will not be given a bed bath, their measurements will be made simultaneously with the experimental group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bed bath | Experimental | Other: bed bath applicationBed 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℃). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The first degree relative who voluntarily accepted to participate in the research gave consent to participate in the research,
- 18 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bed bath applicationPatients 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. | Other | bed bath |
Primary outcome
H1: Bed bath applied to palliative care patients has a saturation regulating effect
Time frame: 1 weeks
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.
H3: Bed bath applied to palliative care patients has an effect on the patients' sleep quality.
Time frame: 1 weeks
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.
H2: Bed bath applied to palliative care patients has an effect on changing the pain level of the patients.
Time frame: 1 weeks
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mihraç Topçu principal investigator
mihrac.topcu1@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bed bath application in people with Palliative Care, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
H1: Bed bath applied to palliative care patients has a saturation regulating effect (time frame: 1 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.