Physiological ParametersNCT06488729
Foot Massage Applied Before a Bronchoscopy Procedure on Physiological Parameters and Anxiety
A study testing Foot massage in people with Physiological Parameters and Anxiety, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physiological Parameters, Anxiety, Bronchoscopy
- What is being tested?
- Foot massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 4 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patients who underwent emergency bronchoscopy patients who do not want to participate in the research voluntarily
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Turkey
Istanbul, Üsküdar
About this study
Official title: Effectiveness of Foot Massage Applied Before a Bronchoscopy Procedure on Physiological Parameters and Anxiety: A Randomized Controlled Study
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.
Read the 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.
- Conditions
- Physiological Parameters, Anxiety, Bronchoscopy
- Being tested
- Foot massage
- Keywords
- foot massage, anxiety, physiological parameters, bronchoscopy, randomized controlled trial
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot massageOther
Foot massage
| Study group | Role | What they receive |
|---|---|---|
| Foot massage | Experimental | Foot massage was applied to the patients in the foot massage group. Receives: Other: Foot massage |
| Control | No intervention | No procedures were applied to the control group other than clinical standard protocols. |
What is being measured
The primary outcome is the main question the study is designed to answer.
physiological parameters
systolic blood pressure (mmHg)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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 (%))
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 Aug 2022
- Primary completion2 Sep 2022
- Study completion4 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological ParametersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488729
- Sponsor's protocol ID
- Semra Aciksoz
- Status last verified
- Apr 2024
- First submitted
- 31 May 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All information about the research can be shared
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Foot Massage Applied Before a Bronchoscopy Procedure on Physiological Parameters and Anxiety: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06488729
- Acronym / sponsor ID
- Semra Aciksoz
- Conditions
- Physiological Parameters, Anxiety, Bronchoscopy
- Keywords
- foot massage, anxiety, physiological parameters, bronchoscopy, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 2 Sep 2022 (actual)
- Study completion
- 4 Feb 2023 (actual)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Foot massage | Experimental | Other: Foot massageFoot massage was applied to the patients in the foot massage group. |
| Control | No intervention | –No procedures were applied to the control group other than clinical standard protocols. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- patients who underwent emergency bronchoscopy patients who do not want to participate in the research voluntarily
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foot massageFoot massage | Other | Foot massage |
Primary outcome
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)
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)
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)
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)
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 (%))
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Individual participant dataSharing planned: Yes. All information about the research can be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot massage in people with Physiological Parameters and Anxiety, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024; AzTrials last refreshed its copy on 1 Nov 2026.