Foot Massage Applied Before a Bronchoscopy Procedure on Physiological Parameters and Anxiety

NCT06488729 | Completed

• 1 other identifier: Semra Aciksoz
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled trial is to assess the effectiveness of foot massage on physiological parameters and anxiety in patients undergoing bronchoscopy. The main questions it aims to answer are:

• Does foot massage applied before bronchoscopy affect physiological parameters?
• Does foot massage before bronchoscopy affect anxiety? Patients in the intervention group received foot massage once before bronchoscopy. Patients in the control group did not receive any treatment other than routine care.

Conditions

Physiological Parameters; Anxiety; Bronchoscopy

Keywords

foot massage; anxiety; physiological parameters; bronchoscopy; randomized controlled trial

Outcome Measures

Primary Outcomes (6)

• physiological parameters

  systolic blood pressure (mmHg)

  The data of the groups were collected during the first arrival of the individuals (before the massage), 40 minutes after the first measurement (after the massage), and following bronchoscopy.

• physiological parameters

  diastolic blood pressure (mmHg)

  The data of the groups were collected during the first arrival of the individuals (before the massage), 40 minutes after the first measurement (after the massage), and following bronchoscopy.

• physiological parameters

  heart rate (beats per minute (min-1 or bpm)

  The data of the groups were collected during the first arrival of the individuals (before the massage), 40 minutes after the first measurement (after the massage), and following bronchoscopy.

• physiological parameters

  respiratory rate (per minute)

  The data of the groups were collected during the first arrival of the individuals (before the massage), 40 minutes after the first measurement (after the massage), and following bronchoscopy.

• physiological parameters

  oxygen saturation (percent (%))

  The data of the groups were collected during the first arrival of the individuals (before the massage), 40 minutes after the first measurement (after the massage), and following bronchoscopy.

• anxiety

  The State Anxiety Inventory

  The data of the groups were collected during the first arrival of the individuals (before the massage), 40 minutes after the first measurement (after the massage), and following bronchoscopy.

Study Arms (2)

Foot massage

EXPERIMENTAL

Foot massage was applied to the patients in the foot massage group.

Other: Foot massage

Control

NO INTERVENTION

No procedures were applied to the control group other than clinical standard protocols.

Interventions

Foot massage OTHER

Foot massage

Foot massage

Eligibility Criteria

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

You may qualify if:

• aged ≥18 years communicate verbally be conscious no lesions on the feet or any problems that may affect the feet (diabetes, neurological disorder, etc.), no previous history of bronchoscopy no history of problems or anxiety no history of any disorder no acute pain no use of opioids or strong sedatives in the last week before recruitment to the study

You may not qualify if:

• patients who underwent emergency bronchoscopy patients who do not want to participate in the research voluntarily

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

University of Health Sciences Turkey

Istanbul, Üsküdar, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: To prevent interaction between groups, the data collection process of the control group was completed first. The researchers were not blinded to the groups, but the statistician was.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patients were separated into two groups with the randomisation method. These groups were named the foot massage group and the control group

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: July 5, 2024
• Study Start: August 1, 2022
• Primary Completion: September 2, 2022
• Study Completion: February 4, 2023
• Last Updated: July 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2024-....

Locations

TU (1)