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Clinical Trials/NCT06488729
NCT06488729CompletedNot Applicable

Effectiveness of Foot Massage Applied Before a Bronchoscopy Procedure on Physiological Parameters and Anxiety: A Randomized Controlled Study

Saglik Bilimleri Universitesi2 sites in 2 countries80 target enrollmentStarted: August 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
80
Locations
2
Primary Endpoint
anxiety

Study Overview

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.

Detailed Description

After the ethics committee and institutional permissions were obtained, patients scheduled for bronchoscopy were evaluated by the researcher for eligibility. First of all, they were informed about the study. Those who agreed to participate and delivered written consent were included in the sample. Individuals were assigned to the intervention and control groups by using block randomization. To prevent interaction between groups, the data collection process of the control group was completed first.A Personal Information Form, the State-Trait Anxiety Inventory, and a Vital Signs Monitoring Form were used to collect study data. In the control group, data were collected during the first arrival of the individuals (T1), 40 minutes after T1 (T2), and following bronchoscopy (T3). No procedures were applied to the control group other than clinical protocols. After the data collection process of the study was completed, the questions of the patients in the control group were answered.

The data of the intervention group were collected during the first arrival of the individuals (before the massage) (T1), 40 minutes after T1 (after the massage) (T2), and following bronchoscopy (T3).

Massage sessions lasted approximately 40 minutes, including 20 minutes for each foot.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Participant, Outcomes Assessor)

Masking Description

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.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

anxiety

Time Frame: 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.

The State Anxiety Inventory

physiological parameters

Time Frame: 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.

systolic blood pressure (mmHg)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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