Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-02-27 @ 4:07 PM
Study NCT ID:
NCT05032469
Status:
COMPLETED
Last Update Posted:
2023-07-18
First Post:
2021-08-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Foot Reflexology to Reduce Pain and Anxiety Before Chest Tube Removal
Sponsor:
Baskent University
Organization:
Study Overview
Official Title:
Effect of The Foot Reflexology Applied Before Chest Tube Removal on the Pain And Anxiety Level: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In open heart surgeries, patients experience severe pain due to tissue trauma, damage to intercostal nerves, and muscle spasm due to pulling tubes from the mediastinal space and between the pleural leaves pull during chet tube removal (CTR). When acute pain is not relieved, the patient develops emotional, psychological (eg post-traumatic stress disorder) and physical problems (eg chronic pain) after surgery. Since this situation negatively affects the healing process, it increases the anxiety level of the patients and decreases the comfort level. Reflexology is one of the non-pharmacological methods used in the management of pain and anxiety after open heart surgery The aim of this randomized controlled study was to identify the effect of foot reflexology applied before chest tube removal process on pain and anxiety level. This study will be done a randomized-controlled trial to test the intervention.
Detailed Description:
Background: Patients undergoing cardiovascular surgery suffer from anxiety and pain due to the chest tube removal (CTR).
Objective/Hypothesis: The aim of this randomized controlled study was to identify the effect of foot reflexology applied before chest tube removal process on pain and anxiety level.The following hypotheses (H) were tested in this study:
H1a : There was a difference between the reflexology group and the control group in terms of pain level during CTR.
H1b : There was a difference between the reflexology group and the control group in terms of anxiety level during CTR.
H1c : There was a difference between the reflexology group and the control group in terms of the difference between the pain level before CTR and during CTR.
H1d : There was a difference between the reflexology group and the control group in terms of the difference between the anxiety level before CTR and during CTR.
Study design: A randomized controlled trial. Method: The study sample who has gone through coronary artery bypass graft surgery was randomly assigned to reflexology or the control group (twenty- eight each in). The primary outcomes were pain, evaluated using a numeric pain-rating scale, and anxiety evaluated by the profile of mood states scale tension-anxiety subscale, both measured first (before and after reflexology) and second postoperative days (before the reflexology and immediately after chest tube removal, 15th minutes and 1 h).
Objective/Hypothesis: The aim of this randomized controlled study was to identify the effect of foot reflexology applied before chest tube removal process on pain and anxiety level.The following hypotheses (H) were tested in this study:
H1a : There was a difference between the reflexology group and the control group in terms of pain level during CTR.
H1b : There was a difference between the reflexology group and the control group in terms of anxiety level during CTR.
H1c : There was a difference between the reflexology group and the control group in terms of the difference between the pain level before CTR and during CTR.
H1d : There was a difference between the reflexology group and the control group in terms of the difference between the anxiety level before CTR and during CTR.
Study design: A randomized controlled trial. Method: The study sample who has gone through coronary artery bypass graft surgery was randomly assigned to reflexology or the control group (twenty- eight each in). The primary outcomes were pain, evaluated using a numeric pain-rating scale, and anxiety evaluated by the profile of mood states scale tension-anxiety subscale, both measured first (before and after reflexology) and second postoperative days (before the reflexology and immediately after chest tube removal, 15th minutes and 1 h).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: