Postoperative CareNCT04070911
Management of Thirst, Nursing Care, Postoperative Care
A study testing WATER and ICE APPLICATION in people with Postoperative Care and Nursing Caries, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The study was conducted to determine the effect of oral water and ice popsicle on management of thirst in the immediate postoperative period as experimental. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Care, Nursing Caries
- What is being tested?
- WATER and ICE APPLICATION
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Nov 2015to 13 Jul 2018
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- have a surgical operation other than gastrointestinal system surgery,
- Surgical fasting duration is at least 8 hours,
- According to the American Society of Anesthesiologists (ASA) classification; Class I, II and III;
- Having the ability to express the thirst status verbally and experiencing moderate or severe thirst when the thirst status is evaluated by VAS,
- The duration of anesthesia is longer than 1 hour and accepted into the PACU after surgery.
Who cannot join
- have a second surgical intervention during hospitalization,
- The need of intensive care after surgery,
- Having problems in the process of separation from respiratory support after surgical intervention,
- A change in the state of consciousness after surgical intervention / acute confusion,
- Liquid electrolyte imbalance,
- Patients with difficulty in swallowing or restriction of oral fluid intake,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Oral Water and Ice Popsicle on Management of Thirst in the Immediate Postoperative Period.
The study was conducted to determine the effect of oral water and ice popsicle on management of thirst in the immediate postoperative period as experimental.
Read the detailed description
Also, it is aimed to evaluate validity and reliability of "Safety Protocol for Management Thirst in the Immediate Postoperative Period Protocol" which is used to take oral water and ice of patients in the immediate postoperative period, as administrative. The study was conducted with 150 patients who are transferred to the postanesthesia care unit (PACU) after their operation and met study criteria. Patients divided into three groups as the study (water group=50, ice group=50) and control (n=50). Patients in the study group were performed oral water/ice popsicle after their accession to PACU. However, the control group patients have performed rutin treatment and care without any other intervention. Physiologic variables and symptoms with thirst were followed in every three group patients at certain times. Data were evaluated by using NCSS (Number Cruncher Statistical System) 2007 program.
- Conditions
- Postoperative Care, Nursing Caries
- Being tested
- WATER, ICE APPLICATION
- Keywords
- Perioperative nursing, Postanesthesia care, Thirst, Water, Ice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WATEROther
ORAL WATER
ICE APPLICATIONOther
ICE APPLICATION
| Study group | Role | What they receive |
|---|---|---|
| patients in the water group | Experimental | water group: Patients in the water group were performed oral water after their accession to PACU. Receives: Other: WATER |
| patients in the ice group | Experimental | ice group, Patients in the ice group were performed oral ice popsicle after their accession to PACU. Receives: Other: ICE APPLICATION |
| no intervention group | No intervention | control group, the control group patients have performed rutin treatment and care without any other intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
THIRSTY SCALE
Thirsty and symptoms of thırsty evaluated via vısual analog scale which containing numbers from zero to ten (0-10), "0" is the minumun point, "10" is the maximum point, higher values represent a better situation.
Measured: first 30 minutes after the surgery
Secondary outcomes (4)
The blood pressure measurements in the first 30 minutes after surgery
Blood pressure was obtained from the monitor data of patients who were monitored postoperatively. Blood pressure was measured as "mmHg".
Measured: first 30 minutes after surgery
The heart rate measurements in the first 30 minutes after surgery
Heart rate was obtained from the monitor data of patients who were monitored postoperatively. heart rate refers to the number of beats per minute.
Measured: first 30 minutes after surgery
The respiratory rate measurements in the first 30 minutes after surgery
The respiratory rate was obtained from the monitor data of the patients who were monitored postoperatively. respiration rate is the sum of inspiration and expiration per minute.
Measured: first 30 minutes after surgery
The body temperature measurements in the first 30 minutes after surgery
Body temperature was obtained from the monitor data of patients who were monitored postoperatively. body temperature was recorded with the degree system in degrees Celsius.
Measured: first 30 minutes after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start24 Nov 2015
- Primary completion13 Jul 2018
- Study completion13 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative CareStudies 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
- RANDOMIZED CONTROLLED STUDY GROUP
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, esra eren, Istanbul Medipol University Hospital
- Investigators
- seher deniz öztekin, Prof.Dr., Study director, thesis advisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070911
- Sponsor's protocol ID
- 55323
- Status last verified
- Aug 2019
- First submitted
- 23 May 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Water and Ice Popsicle on Management of Thirst in the Immediate Postoperative Period.
- ClinicalTrials.gov ID
- NCT04070911
- Acronym / sponsor ID
- 55323
- Conditions
- Postoperative Care, Nursing Caries
- Keywords
- Perioperative nursing, Postanesthesia care, Thirst, Water, Ice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 24 Nov 2015 (actual)
- Primary completion
- 13 Jul 2018 (actual)
- Study completion
- 13 Jul 2018 (actual)
- First posted
- 28 Aug 2019 (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 study was conducted to determine the effect of oral water and ice popsicle on management of thirst in the immediate postoperative period as experimental.
Detailed description
Also, it is aimed to evaluate validity and reliability of "Safety Protocol for Management Thirst in the Immediate Postoperative Period Protocol" which is used to take oral water and ice of patients in the immediate postoperative period, as administrative. The study was conducted with 150 patients who are transferred to the postanesthesia care unit (PACU) after their operation and met study criteria. Patients divided into three groups as the study (water group=50, ice group=50) and control (n=50). Patients in the study group were performed oral water/ice popsicle after their accession to PACU. However, the control group patients have performed rutin treatment and care without any other intervention. Physiologic variables and symptoms with thirst were followed in every three group patients at certain times. Data were evaluated by using NCSS (Number Cruncher Statistical System) 2007 program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- RANDOMIZED CONTROLLED STUDY GROUP
| Arm | Type | Receives |
|---|---|---|
| patients in the water group | Experimental | Other: WATERwater group: Patients in the water group were performed oral water after their accession to PACU. |
| patients in the ice group | Experimental | Other: ICE APPLICATIONice group, Patients in the ice group were performed oral ice popsicle after their accession to PACU. |
| no intervention group | No intervention | –control group, the control group patients have performed rutin treatment and care without any other intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- have a surgical operation other than gastrointestinal system surgery,
- Surgical fasting duration is at least 8 hours,
- According to the American Society of Anesthesiologists (ASA) classification; Class I, II and III;
- Having the ability to express the thirst status verbally and experiencing moderate or severe thirst when the thirst status is evaluated by VAS,
- The duration of anesthesia is longer than 1 hour and accepted into the PACU after surgery.
Key exclusion criteria (6 listed)
- have a second surgical intervention during hospitalization,
- The need of intensive care after surgery,
- Having problems in the process of separation from respiratory support after surgical intervention,
- A change in the state of consciousness after surgical intervention / acute confusion,
- Liquid electrolyte imbalance,
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 |
|---|---|---|
| WATERORAL WATER | Other | patients in the water group |
| ICE APPLICATIONICE APPLICATION | Other | patients in the ice group |
Primary outcome
THIRSTY SCALE
Time frame: first 30 minutes after the surgery
Thirsty and symptoms of thırsty evaluated via vısual analog scale which containing numbers from zero to ten (0-10), "0" is the minumun point, "10" is the maximum point, higher values represent a better situation.
4 secondary outcomes
The blood pressure measurements in the first 30 minutes after surgery
Time frame: first 30 minutes after surgery
The heart rate measurements in the first 30 minutes after surgery
Time frame: first 30 minutes after surgery
The respiratory rate measurements in the first 30 minutes after surgery
Time frame: first 30 minutes after surgery
The body temperature measurements in the first 30 minutes after surgery
Time frame: first 30 minutes after surgery
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 28 Aug 2019.
- Individual participant dataSharing planned: No
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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.
seher deniz öztekin, Prof.Dr. study director
thesis advisor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WATER and ICE APPLICATION in people with Postoperative Care and Nursing Caries, run by Istanbul Medipol University Hospital 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 5 inclusion and 6 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 28 Aug 2019. 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?
THIRSTY SCALE (time frame: first 30 minutes after the surgery). 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 28 Aug 2019.