Clinical trial NCT06488729: Foot Massage Applied Before a Bronchoscopy Procedure on Physiological Parameters and Anxiety
Official title: Effectiveness of Foot Massage Applied Before a Bronchoscopy Procedure on Physiological Parameters and Anxiety: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physiological Parameters
Anxiety
Bronchoscopy
Keywords: foot massage
anxiety
physiological parameters
bronchoscopy
randomized controlled trial
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients were separated into two groups with the randomisation method. These groups were named the foot massage group and the control group
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: physiological parameters
timeFrame: 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.
measure: physiological parameters
timeFrame: 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.
measure: physiological parameters
timeFrame: 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.
measure: physiological parameters
timeFrame: 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.
measure: physiological parameters
timeFrame: 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.
measure: anxiety
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: University of Health Sciences Turkey
state: Üsküdar
Study officials:
References: