Pressure InjuryPWNCT05132634
The Effect of Massage in Preventing Pressure Wound Development
A study testing Hand Massage in people with Pressure Injury, run by Giresun University at 1 site in Turkey (Türkiye).
Trial summary
Pressure Wound (PW) is a chronic wound that develops in soft tissue as a result of the capillary end pressure which rising above 32 mmHg. It is the most common complication with 31% annual incidence after spinal cord injuries. Pressure wound is considered as malpractice for nursing practices. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Injury
- What is being tested?
- Hand Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 29 Nov 2022
- 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
- Being in the intensive care unit, being 18 years or older,
- Braden Risk Assessment Scale score 12 and below,
- Patients whose position change is within the scope of the physician's request (patients whose position change is not restricted such as spinal cord injury, orthopedic surgery),
- Conscious patients willing to participate in the study or obtaining permission from family members in the unconscious.
Who cannot join
- Having a Braden Risk Assesment Scale (BRAS) score of 12 and above,
- Staying in the intensive care unit for less than five days, Pressure wound Stage 1 and above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Hand Massage in Prevention of Pressure Wound
Pressure Wound (PW) is a chronic wound that develops in soft tissue as a result of the capillary end pressure which rising above 32 mmHg. It is the most common complication with 31% annual incidence after spinal cord injuries. Pressure wound is considered as malpractice for nursing practices. It decreases the quality of life of the elderly and patients with mobility restrictions and prolongs the length of hospital stay. Complication development risk and cost are high. Factors affecting wound opening include the amount of pressure, duration, moisture, friction, nutrition, age, weight, hemoglobin value, chronic diseases. The development of preventive actions, protocol and standard in pressure wound planning of care is among the main goals of nursing care. The research will be carried out to evaluate the effect of hand massage in preventing pressure injuries. Patient with a high risk of developing pressure wound will constitute the experimental and control group of our study. Standard nursing care applied to the control group; unlike the control group hand massage will be applied to the experiment group.when the sample group determined in both the experimental and control groups is reached the study will be terminated. The pressure wound in both groups will be compared statistically and the effectiveness of hand massage in reducing the pressure wound will be determined.
H0 :The applied classical hand massage has no effect on the formation of pressure wound.
H1: The applied classical hand massage has effect on the formation of pressure wound.
Read the detailed description
Background: According to the National Pressure Ulcer Association Panel (NPUAP) data, the incidence of pressure wounds (PW) in acute care units varies between 0.4-38%, in long-term care units 2.2-23.9%. While it is stated that more than 700,000 patients develop PW each year in the UK and 180,000 of them start in the hospital, PW is a significant health burden affecting more than 2.5 million adults per year in the United States (USA) and will affect the growing elderly population in the future. According to the National Health Service (NHS), it is claimed that the daily cost of treatment applied in the treatment of PW is more than 3.8 million. European Pressure Ulcer Association Panel (EPUAP) according to, PW is defined as localized skin/subcutaneous tissue damage, usually occurring on bone prominences, caused by additional factors together with pressure or shearing. It is said that hand massage is effective in preventing the development of PW; when the literature results are examined, it has been determined that there are insufficient studies at the level of evidence to measure the effectiveness of massage applications or hand massage. Therefore, our study, it was aimed to evaluate the effect of classical hand massage on the prevention of PW.
Method: A total of 60 patients over the age of 18 who were hospitalized in the intensive care unit of the hospital with undeveloped PW and who had not undergone surgery were randomly assigned to the experimental and control groups. The patients included in the experimental group were massaged twice a day, in the morning and evening, together with nursing care, for 15-20 minutes. Admitted to the control group. only nursing care was applied to the basta. Due to the lack of a clear time for PW development in the literature, patients; In the hospital where the research was conducted, patients were followed up for 12 days, since the average duration of opening RF was 12 days in 2019-2020. Patients who were opened BY were followed up until the day they were opened.
- Conditions
- Pressure Injury
- Being tested
- Hand Massage
- Keywords
- Massage, Nursing Care, Pressure Ulcer, Therapeutic touch
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand MassageOther
Like a massage, the superficial kneading technique which is included in the Swedish massage technique will be applied in a way to create a slight pressure on the patient, and it will be terminated again with the effleurage technique. The procedure was concluded in a way that each massage technique was applied and the massage was for a total of 15-20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Arms | Experimental | Experimental Group:
Braden Risk Assessment Scale was completed on the first day of admission to the Intensive Care Unit and every morning in the morning.
Since the care hours were between 08:00_10:00 in the morning and 20:00-22:00 at night, classical hand massage was applied to the patient by the researcher between the time zones specified daily.
It was followed up with the Pressure Wound Staging Form.
Control Group:
The Braden Risk Assessment Scale was completed on the first day of admission to the Intensive Care Unit and every morning in the morning.
It was followed up with the Pressure Wound Staging Form. Receives: Other: Hand Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Information Form
The form (22, 52) developed by the researcher in line with the literature, the patient group (experimental, control), age, gender, presence of chronic disease, current chronic disease, physical evaluation (height, weight, body mass index), hospitalization cause/diagnosis, fluid intake and nutritional status, pressure ulcer formation status, number, region, day and time of occurrence, Braden Risk Assessment Scale score. Of these statements, 11 are for all patients in both groups with and without pressure ulcers, and four for patients who only develop pressure ulcers. The data in this form were collected through observation and obtained from the nurse observation form.Sociodemographic characteristics of the patients will be measured.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start1 Mar 2021
- Primary completion1 Sep 2021
- Study completion29 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuryStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Paralel Assignment randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Ozkan, Giresun University
- Investigators
- Esra Özkan, Lecturer, Principal investigator, Giresun University Health Servives Vocational School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132634
- Sponsor's protocol ID
- Giresun University
- Acronym
- PW
- Status last verified
- Feb 2023
- First submitted
- 27 Oct 2021
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Hand Massage in Prevention of Pressure Wound
- ClinicalTrials.gov ID
- NCT05132634
- Acronym / sponsor ID
- PW / Giresun University
- Conditions
- Pressure Injury
- Keywords
- Massage, Nursing Care, Pressure Ulcer, Therapeutic touch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 24 Nov 2021 (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.
Pressure Wound (PW) is a chronic wound that develops in soft tissue as a result of the capillary end pressure which rising above 32 mmHg. It is the most common complication with 31% annual incidence after spinal cord injuries. Pressure wound is considered as malpractice for nursing practices. It decreases the quality of life of the elderly and patients with mobility restrictions and prolongs the length of hospital stay. Complication development risk and cost are high. Factors affecting wound opening include the amount of pressure, duration, moisture, friction, nutrition, age, weight, hemoglobin value, chronic diseases. The development of preventive actions, protocol and standard in pressure wound planning of care is among the main goals of nursing care. The research will be carried out to evaluate the effect of hand massage in preventing pressure injuries. Patient with a high risk of developing pressure wound will constitute the experimental and control group of our study. Standard nursing care applied to the control group; unlike the control group hand massage will be applied to the experiment group.when the sample group determined in both the experimental and control groups is reached the study will be terminated. The pressure wound in both groups will be compared statistically and the effectiveness of hand massage in reducing the pressure wound will be determined.
H0 :The applied classical hand massage has no effect on the formation of pressure wound.
H1: The applied classical hand massage has effect on the formation of pressure wound.
Detailed description
Background: According to the National Pressure Ulcer Association Panel (NPUAP) data, the incidence of pressure wounds (PW) in acute care units varies between 0.4-38%, in long-term care units 2.2-23.9%. While it is stated that more than 700,000 patients develop PW each year in the UK and 180,000 of them start in the hospital, PW is a significant health burden affecting more than 2.5 million adults per year in the United States (USA) and will affect the growing elderly population in the future. According to the National Health Service (NHS), it is claimed that the daily cost of treatment applied in the treatment of PW is more than 3.8 million. European Pressure Ulcer Association Panel (EPUAP) according to, PW is defined as localized skin/subcutaneous tissue damage, usually occurring on bone prominences, caused by additional factors together with pressure or shearing. It is said that hand massage is effective in preventing the development of PW; when the literature results are examined, it has been determined that there are insufficient studies at the level of evidence to measure the effectiveness of massage applications or hand massage. Therefore, our study, it was aimed to evaluate the effect of classical hand massage on the prevention of PW.
Method: A total of 60 patients over the age of 18 who were hospitalized in the intensive care unit of the hospital with undeveloped PW and who had not undergone surgery were randomly assigned to the experimental and control groups. The patients included in the experimental group were massaged twice a day, in the morning and evening, together with nursing care, for 15-20 minutes. Admitted to the control group. only nursing care was applied to the basta. Due to the lack of a clear time for PW development in the literature, patients; In the hospital where the research was conducted, patients were followed up for 12 days, since the average duration of opening RF was 12 days in 2019-2020. Patients who were opened BY were followed up until the day they were opened.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Paralel Assignment randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Arms | Experimental | Other: Hand MassageExperimental Group: Braden Risk Assessment Scale was completed on the first day of admission to the Intensive Care Unit and every morning in the morning. Since the care hours were between 08:00_10:00 in the morning and 20:00-22:00 at night, classical hand massage was applied to the patient by the researcher between the time zones specified daily. It was followed up with the Pressure Wound Staging Form. Control Group: The Braden Risk Assessment Scale was completed on the first day of admission to the Intensive Care Unit and every morning in the morning. It was followed up with the Pressure Wound Staging Form. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being in the intensive care unit, being 18 years or older,
- Braden Risk Assessment Scale score 12 and below,
- Patients whose position change is within the scope of the physician's request (patients whose position change is not restricted such as spinal cord injury, orthopedic surgery),
- Conscious patients willing to participate in the study or obtaining permission from family members in the unconscious.
Key exclusion criteria (2 listed)
- Having a Braden Risk Assesment Scale (BRAS) score of 12 and above,
- Staying in the intensive care unit for less than five days, Pressure wound Stage 1 and above
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 |
|---|---|---|
| Hand MassageLike a massage, the superficial kneading technique which is included in the Swedish massage technique will be applied in a way to create a slight pressure on the patient, and it will be terminated again with the effleurage technique. The procedure was concluded in a way that each massage technique was applied and the massage was for a total of 15-20 minutes. | Other | Arms |
Primary outcome
Patient Information Form
Time frame: 6 months
The form (22, 52) developed by the researcher in line with the literature, the patient group (experimental, control), age, gender, presence of chronic disease, current chronic disease, physical evaluation (height, weight, body mass index), hospitalization cause/diagnosis, fluid intake and nutritional status, pressure ulcer formation status, number, region, day and time of occurrence, Braden Risk Assessment Scale score. Of these statements, 11 are for all patients in both groups with and without pressure ulcers, and four for patients who only develop pressure ulcers. The data in this form were collected through observation and obtained from the nurse observation form.Sociodemographic characteristics of the patients will be measured.
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 23 Feb 2023.
- https://www.sciencedirect.com/science/article/pii/S0020748921001619Link provided by the sponsor.
- 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.
Esra Özkan, Lecturer principal investigator
Giresun University Health Servives Vocational School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand Massage in people with Pressure Injury, run by Giresun 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 2 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 23 Feb 2023. 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?
Patient Information Form (time frame: 6 months). 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 23 Feb 2023.