Unique ID issued by UMIN | UMIN000052914 |
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Receipt number | R000060373 |
Scientific Title | Effect of body position exchange on dyspnea associated with single-sided pleural effusion in cancer patients: A randomized, crossover, controlled trial |
Date of disclosure of the study information | 2023/11/30 |
Last modified on | 2023/11/27 15:20:00 |
Effect of body position exchange on dyspnea associated with single-sided pleural effusion in cancer patients: A randomized, crossover, controlled trial
Effect of body position exchange on dyspnea associated with single-sided pleural effusion in cancer patients: A randomized, crossover, controlled trial
Effect of body position exchange on dyspnea associated with single-sided pleural effusion in cancer patients: A randomized, crossover, controlled trial
Effect of body position exchange on dyspnea associated with single-sided pleural effusion in cancer patients: A randomized, crossover, controlled trial
Japan |
Cancer
Nursing |
Malignancy
NO
To evaluate the effect of changing positions between the healthy side lying position and the sick side lying position on alleviating dyspnea.
Safety
1) Difference in dyspnea NRS before and after comparison between the healthy side lying position and the sick side lying position
1) Whether dyspnea was relieved following each intervention
2) Percentage of cases in which the dyspnea NRS decreased by 1 or more with each intervention
3) Exploration of factors associated with improvement in dyspnea
4) Percentage of patients who responded when asked which intervention was better, the healthy side lying position or the sick side lying position.
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Active
2
Treatment
Maneuver | Other |
1) The patient is placed in supine rest for 5 minutes. The baseline (Ti0) will be set at that point, and the dyspnea NRS will be measured. The bed angle should be between 0 and 45 degrees.
2) The patient is placed in a supine position on the healthy side with the assistance of one or more medical personnel and allowed to rest for 5 minutes. The dyspnea NRS is measured at Ti1.
3) After 5 minutes of rest in the healthy side supine position, the patient is changed to the supine position with the assistance of one or more medical personnel.
4) During the recovery period, the dyspnea NRS is measured every 15 minutes at 15 minutes (Ti15), 30 minutes (Ti30), 45 minutes (Ti45), and 60 minutes (Ti60) after the intervention, and the patient is observed for up to 60 minutes until the dyspnea NRS returns to the baseline (Ti0) level.
5) Perform the intervention in the sick side supine position and measure the dyspnea NRS.
1) The patient is placed in supine rest for 5 minutes. The baseline (Ti0) will be set at that point, and the dyspnea NRS will be measured. The bed angle should be between 0 and 45 degrees.
2) The patient is placed in a supine position on the scik side with the assistance of one or more medical personnel and allowed to rest for 5 minutes. The dyspnea NRS is measured at Ti1.
3) After 5 minutes of rest in the healthy side supine position, the patient is changed to the supine position with the assistance of one or more medical personnel.
4) During the recovery period, the dyspnea NRS is measured every 15 minutes at 15 minutes (Ti15), 30 minutes (Ti30), 45 minutes (Ti45), and 60 minutes (Ti60) after the intervention, and the patient is observed for up to 60 minutes until the dyspnea NRS returns to the baseline (Ti0) level.
5) Perform the intervention in the healthy side supine position and measure the dyspnea NRS.
18 | years-old | <= |
Not applicable |
Male and Female
1)Patients with cancer who have given consent to participate in this study
2)Age greater than or equal to 18 years
3)Dyspnea NRS greater than or equal to 3
4)Pleural effusion more than or uqual to 1/3 on one side on standing or seated chest radiographs or CT images taken within 2 weeks prior to enrollment
5)Hb greater than or uqual to 6g/dL on the most recent blood test within 2 weeks prior to enrollment
6)SpO2 greater than or equal to 90% (oxygen can be administered)
7)Patient has clear consciousness, no cognitive impairment, and can read, write, and communicate in Japanese.
1)Patients who have undergone lung resection surgery in the past
2)Patients with more than 1/3 of chest effusion bilaterally on the most recent standing or sitting chest radiographs.
3)performing opioid rescue more than 9 times a day
4)Patients who have undergone any treatment or procedure (e.g., pleurodesis, blood transfusion) since radiography or CT scan and blood test 2 weeks prior to enrollment that would affect the data
5)Patients whose disease, medical condition, or symptoms may be aggravated by the positioning of the body
6)Other patients deemed inappropriate by the physician in charge for this study.
90
1st name | Kako |
Middle name | |
Last name | Jun |
Mie University
Gra
514-8507
2-174 Edobashi, Tsu City, Mie
059-231-5091
jkako@med.mi-eu.ac.jp
1st name | Kako |
Middle name | |
Last name | Jun |
Mie University
Graduate School of Medicine
514-8507
2-174 Edobashi, Tsu City, Mie
059-231-5091
jkako@med.mie-u.ac.jp
Mie University
JSPS KAKENHI
Japanese Governmental office
NHO Kinki Chuo Chest Medical Center
1180 Nagasone-cho, Kita-ku, Sakai, Osaka
072-252-3021
oguni.shun.fp@mail.hosp.go.jp
YES
2023-68
NHO Kinki Chuo Chest Medical Center
2023 | Year | 11 | Month | 30 | Day |
Unpublished
Preinitiation
2023 | Year | 10 | Month | 31 | Day |
2023 | Year | 10 | Month | 31 | Day |
2024 | Year | 07 | Month | 01 | Day |
2028 | Year | 10 | Month | 31 | Day |
2023 | Year | 11 | Month | 27 | Day |
2023 | Year | 11 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060373
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