Effect of Foot Reflexology on Pain Associated With Mediastinal Chest Drain Removal

NCT05631522 | Unknown

• 1 other identifier: P.0235
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cardiovascular diseases (CVDs) remain the leading cause of death worldwide and significantly affect patient quality of life and socioeconomic status. The care of CVD patients in Egypt is very complex and sensitive because of the high incidence and high mortality rate. The burden of CVD and the high prevalence of CVD risk factors in Egypt are alarming. Despite great evidence of adverse clinical impact, the pain remains infrequently assessed and poorly managed in ICU. Pain has serious physical and psychological effects which can impair patient recovery and discharge. Moreover, it does not allow the patients to collaborate appropriately during care-related procedures, such as mobilization and respiratory therapy.

Conditions

Foot Reflexology

Outcome Measures

Primary Outcomes (1)

• Efficacy of foot reflexology on pain

  Incidence of pain during chest drain removal. Pain assessed by NRS \[The scoring system is interpreted as 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain\] and CPOT scale \[This pain assessment tool evaluates four clinical components: facial expressions, body movements, muscle tension, and compliance with the ventilator for mechanically ventilated patients or vocalization for the non-intubated patients. The CPOT score ranges from 2 to 8 and a score of more than 2 require pain management\].

  1 day

Study Arms (2)

foot reflexology group

EXPERIMENTAL

Patients who will receive foot reflexology before and throughout the MCDR procedure.

Other: foot reflexology

control group

NO INTERVENTION

Patients who will receive the routine ICU care during the MCDR procedure.

Interventions

foot reflexology OTHER

Warm-Up Phase: Pre-reflexology foot massage and all-over foot squeeze will be performed for two minutes. Mini-Reflexology Session: Specific reflexology will be performed with special attention to two important foot reflex areas that include: Diaphragm and Solar Plexus Reflex Areas are located in the distance between the upper and middle third of the sole. The Heart and Lung Reflex Areas are located below the chest of the foot. The heart pumps the oxygen-rich blood around the body

foot reflexology group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult conscious patients ≥ 18 years old after OHS, who have a mediastinal chest drain.
• Gender: male and female

You may not qualify if:

• \- 1. Sedated patients 2. Patients with any problem in the foot as a wound, allergy, injury, pain, callus, corn, fungal skin infection, or previous scars.
• \. Patients use analgesics for 6 hours before the intervention.

Sponsors & Collaborators

• Mansoura University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: demonstrator of critical care and emergency nursing

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: November 30, 2022
• Study Start: December 1, 2022
• Primary Completion: January 30, 2023
• Study Completion: February 28, 2023
• Last Updated: November 30, 2022

Record last verified: 2022-11