NCT05132634

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.

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 Mar 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 24, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2022

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

October 27, 2021

Last Update Submit

February 22, 2023

Conditions

Keywords

MassageNursing CarePressure UlcerTherapeutic touch

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Other Outcomes (2)

  • Pressure Wound Staging Form

    6 months

  • Experimental and Control Group Follow-up Form

    6 months

Study Arms (1)

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.

Other: Hand Massage

Interventions

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.

Arms

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Giresun University

Giresun, 28000, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Esra Özkan, Lecturer

    Giresun University Health Servives Vocational School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Paralel Assignment randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

October 27, 2021

First Posted

November 24, 2021

Study Start

March 1, 2021

Primary Completion

September 1, 2021

Study Completion

November 29, 2022

Last Updated

February 23, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations