search
Back to results

The Effect of Massage in Preventing Pressure Wound Development (PW)

Primary Purpose

Pressure Injury

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hand Massage
Sponsored by
Giresun University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pressure Injury focused on measuring Massage, Nursing Care, Pressure Ulcer, Therapeutic touch

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Giresun University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arms

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 27, 2021
Last Updated
February 22, 2023
Sponsor
Giresun University
search

1. Study Identification

Unique Protocol Identification Number
NCT05132634
Brief Title
The Effect of Massage in Preventing Pressure Wound Development
Acronym
PW
Official Title
Evaluation of the Effect of Hand Massage in Prevention of Pressure Wound
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
November 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Giresun University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Injury
Keywords
Massage, Nursing Care, Pressure Ulcer, Therapeutic touch

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Paralel Assignment randomized controlled trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arms
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Hand Massage
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Information Form
Description
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.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Pressure Wound Staging Form
Description
Staging was performed according to the National Pressure Ulcer Panel Pressure Ulcer Injuries Staging System Stage 1: Skin integrity is intact. There is redness that does not fade with pressure on the skin in other areas, mostly bone protrusions. The wound site may be painful, hard, soft, warmer or colder than the surrounding tissues.
Time Frame
6 months
Title
Experimental and Control Group Follow-up Form
Description
It was created by the researcher, using the literature information, in order to follow the patient's laboratory values and the skin in risky areas in terms of the formation of pressure wound. It was recorded for the patients included in the experimental group in the daily experimental group follow-up form by being evaluated every day and at each position hour in terms of A clear disc was used during skin diagnosis to evaluate non-whitening erythema more objectively. When RA developed in the areas under observation, the follow-up of the area with pressure sores was terminated. Since the laboratory values of the patients were checked weekly in the unit where the study was conducted, albumin and hemoglobin values were obtained from the patient file. Laboratory values were evaluated by considering the values in the reference range of the hospital where the research was conducted
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esra Özkan, Lecturer
Organizational Affiliation
Giresun University Health Servives Vocational School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Giresun University
City
Giresun
ZIP/Postal Code
28000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://doi.org/10.1016/j.ijnurstu.2021.104014
Description
https://www.sciencedirect.com/science/article/pii/S0020748921001619

Learn more about this trial

The Effect of Massage in Preventing Pressure Wound Development

We'll reach out to this number within 24 hrs