Clinical trial NCT05132634: The Effect of Massage in Preventing Pressure Wound Development
Official title: Evaluation of the Effect of Hand Massage in Prevention of Pressure Wound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Injury
Keywords: Massage
Nursing Care
Pressure Ulcer
Therapeutic touch
Lead sponsor: Giresun University
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Paralel Assignment randomized controlled trial
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Patient Information Form
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: Pressure Wound Staging Form
timeFrame: 6 months
measure: Experimental and Control Group Follow-up Form
timeFrame: 6 months
Locations:
city: Giresun
country: Turkey
facility: Giresun University
Study officials:
affiliation: Giresun University Health Servives Vocational School
name: Esra Özkan, Lecturer
role: PRINCIPAL_INVESTIGATOR
References: