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Completed

NCT Number: NCT06488729

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

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.

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Key information

Conditions

Physiological Parameters Anxiety Anxiety Disorders Bronchoscopy Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences Turkey

Istanbul, Üsküdar, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

foot massage

Other

Foot massage

Primary outcomes

  1. 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)

  2. 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.

    diastolic blood pressure (mmHg)

  3. 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.

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

  4. 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.

    respiratory rate (per minute)

  5. 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.

    oxygen saturation (percent (%))

  6. 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

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jul 5, 2024
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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