Nursing CariesComfort TheoryNCT04105556
Male Circumcision and Comfort Theory
A study testing Nursing Care Based on Kolcaba's Comfort Theory in people with Nursing Caries, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
Aim: Male circumcision is one of the oldest and most commonly performed surgical procedures in the world and in our country. Circumcision, which concerns such a large population, is a stressful, traumatic, negative experience. Read more about this study
- Who is it for?
- Ages 4 to 7 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Nursing Caries
- What is being tested?
- Nursing Care Based on Kolcaba's Comfort Theory
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Mar 2020
- 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 4 to 7 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- The child is between the ages of 4-7
- No previous surgical experience of the child
- Lack of chronic disease, disability and developmental delay of the child
- The child or his / her parent does not have a special situation that causes difficulties in understanding and perception.
- Parent's ability to read and write in Turkish
Who cannot join
- Child / parent who does not volunteer to participate in the study
- Children who are not cared for at least two relatives during the surgical procedure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Fahriye PAZARCIKCI
Isparta, Türki̇ye, 32100
Fahriye PAZARCIKCI, 05052560327 ext. 05052560327, fahriyepazarcikci@sdu.edu.tr
About this study
Official title: The Effect of Nursing Care Based on Kolcaba's Comfort Theory to the Comfort and Components of the Child and Parents Who Are Planned for Male Circumcision Operation
Aim: Male circumcision is one of the oldest and most commonly performed surgical procedures in the world and in our country. Circumcision, which concerns such a large population, is a stressful, traumatic, negative experience. Impairment in comfort is a condition in which a child who is scheduled for circumcision operation often suffers. Physical, emotional, sociocultural and environmental factors contribute to the formation of this condition. Comfort Theory is a nursing model that makes it easier for the caregivers to see their problems more systematically and to plan more easily. In the literature review, no studies have been found to determine the effect of nursing care based on Kolcaba Konfors Comfort Theory to the comfort and components of the children and their parents who have undergone circumcision operation. Therefore, this study was needed. In this study, nursing care based on Kolcaba's Comfort Theory, which continues throughout the perioperative period, was applied to children and their parents.
Method: In this study, the effect of nursing care based on Kolcaba's Comfort Theory on fear, anxiety, pain, comfort and anxiety in parents and health care satisfaction was tested in children. Care was given when the child and his / her parents applied to the outpatient clinic for anesthesia consultation on the working day before the operation, and care was continued in the day surgery unit. On the 1st and 3rd days after discharge, the researcher provided tele-monitoring and consultancy services. In addition, communication with the parents was maintained at all times as needed. Care was terminated on the 10th day after discharge. The time of the study was approximately 12-14 days for each child and his / her parents.
The sample of the study was determined as 120 boys and their parents (60 control each, 60 intervention each). In this study, standard nursing care will be applied to the control group and nursing care based on Kolcaba's Comfort Theory will be applied to the intervention group. The data will be collected with the Child and Family Descriptive, VAS, Children's State Anxiety (CSA) and Children's Fear Scale (CFS), Comfort Behavior Checklist, Spielberger State Anxiety Scale, PedsQL Health Care Satisfaction Scale.
Read the detailed description
In this study, nursing care based on Kolcaba's Comfort Theory, which continues throughout the perioperative period, was applied to children and their parents.
Care was given when the child and his / her parents applied to the outpatient clinic for anesthesia consultation on the working day before the operation, and care was continued in the day surgery unit. On the 1st and 3rd days after discharge, the researcher provided tele-monitoring and consultancy services. In addition, communication with the parents was maintained at all times as needed. Care was terminated on the 10th day after discharge. The time of the study was approximately 12-14 days for each child and his / her parents.
Nursing care consists of 3 types of comfort-oriented care interventions. These interventions;
- Standard maintenance interventions,
- Emotional focused comfort care interventions,
- Cognitive and functional comfort care interventions.
- Conditions
- Nursing Caries
- Being tested
- Nursing Care Based on Kolcaba's Comfort Theory
- Keywords
- Male Child, Comfort Theory, Fear, Male Circimcision, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing Care Based on Kolcaba's Comfort TheoryOther
Also called • Pre-surgical preparation program • Comfort-oriented care • Tele-monitoring and consultancy
In this study, nursing care based on Kolcaba's Comfort Theory, which continues throughout the perioperative period, was applied to children and their parents.
| Study group | Role | What they receive |
|---|---|---|
| Nursing Care Based on Kolcaba's Comfort Theory | Experimental | In this study, nursing care based on Kolcaba's Comfort Theory, which continues throughout the perioperative period, was applied to children and their parents.
Care was given when the child and his / her parents applied to the outpatient clinic for anesthesia consultation on the working day before the operation, and care was continued in the day surgery unit. On the 1st and 3rd days after discharge, the researcher provided tele-monitoring and consultancy services. In addition, communication with the parents was maintained at all times as needed. Care was terminated on the 10th day after discharge. The time of the study was approximately 12-14 days for each child and his / her parents.
Nursing care consists of 3 types of comfort-oriented care interventions. These interventions;
1. Standard maintenance interventions,
2. Emotional focused comfort care interventions,
3. Cognitive and functional comfort care interventions. Receives: Other: Nursing Care Based on Kolcaba's Comfort Theory |
| Routine hospital schedule | No intervention | The researcher sincerely answered all questions asked by the control group during the perioperative period. After the post-discharge post-tests, the control group was given a gift of medal of courage, a story book and a training booklet prepared for the parents after the policlinic control on the 10th postoperative day, and the training was given to the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort Behaviors Checklist
Comfort Behaviors Checklist was developed in 1989 by Kolcaba. Developed as a last resort, data collectors are used to rate a patient's apparent comfort. While not as desirable as actually asking a patient about his or her comfort, the instrument can fill a gap regarding data collection in comatose, very frail (as in terminal), or cognitively limited patients. Kolcaba and DiMarco (2005) reported that postoperative comfort in children can be assessed using the Comfort Behavior Checklist. The reliability and validity study of our country was conducted by Unutkan and Balcı Yangın (2018).
Measured: In two weeks
VAS
The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. Instructions, time period for reporting, and verbal descriptor anchors have varied widely in the literatüre. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]). Varies, but most commonly respondents are asked to report "current" pain intensity or pain intensity "in the last 24 hours." A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm)
Measured: In two weeks
Children's Fear Scale
It was developed by McMurty et al. (2011). The validity and reliability study of the Turkish Children's Fear Scale was conducted by Özalp Gerçeker and colleagues in 2017. The scale can be used to assess fear in children aged 4-10 years. The CFS consists of five drawn facial expressions ranging from neutral expression (0 = no anxiety) to the frightened face (4 = severe anxiety), and can be easily evaluated by parents, researchers, and healthcare professionals who care for the child. It is a scale of one item. CFS was developed based on the Faces Anxiety Scale developed to measure the anxiety or fear of adults in the intensive care unit of McKinley et al. (2003).
Measured: In two weeks
Children's Anxiety Meter-State (CAM-S)
The scale was developed by Ersig et al. (2013). The Turkish validity and reliability study of the scale was conducted by Özalp Gerçeker et al. The scale can be used to assess anxiety in children aged 4-10 years. The score can vary from 0 to 10 (Ersig et al., 2013)
Measured: In two weeks
The State-Trait Anxiety Inventory (STAI)
In the study, STAI will be used to determine the anxiety of parents. It was developed by Spielberger et al. (1970). The Turkish validity and reliability study of the STAI was conducted by Öner and Le Compte in 1983. The scale is a 4-point Likert type and contains two 20-item expressions. Direct expressions express negative emotions and reversed expressions express positive emotions. It was reported that the Cronbach Alpha internal consistency coefficient ranged between α = 0.83 and 0.87 (Sarıtaş and Büyükbayram, 2016).
Measured: In two weeks
The PedsQL (Pediatric Quality of Life InventoryTM)
The PedsQL will be used to measure the level of health care satisfaction of parents. The scale consists of 25 questions. The questions in the scale are aimed at measuring satisfaction with medical care services and psychosocial satisfaction. Cronbach Alpha internal consistency coefficient of the scale, which was validated by Varni (1999), was found to be α = .96. Scale was adapted to Turkish by Ulus and Kublay (2012).
Measured: In two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start1 Jan 2019
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nursing CariesStudies 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
- Type of intervention, testing the comfort and components of children and parents of the circumcision operation plan with Nursing Care Based on Kolcaba's Comfort Theory
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fahriye Celik, Suleyman Demirel University
- Investigators
- Emine EFE, Study director, Akdeniz Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105556
- Sponsor's protocol ID
- SuleymanDUnursingcare
- Acronym
- Comfort Theory
- Status last verified
- Sep 2019
- First submitted
- 23 Sep 2019
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wagner D, Byrne M, Kolcaba K. Effects of comfort warming on preoperative patients. AORN J. 2006 Sep;84(3):427-48. doi: 10.1016/s0001-2092(06)63920-3.
PubMed 17004666Dowd T, Kolcaba K, Steiner R, Fashinpaur D. Comparison of a healing touch, coaching, and a combined intervention on comfort and stress in younger college students. Holist Nurs Pract. 2007 Jul-Aug;21(4):194-202. doi: 10.1097/01.HNP.0000280931.75883.ae.
PubMed 17627198Dowd T, Kolcaba K. Two interventions to relieve stress in college students. Beginnings. 2007 Winter;27(1):10-1. No abstract available.
PubMed 17381027Kolcaba K, Tilton C, Drouin C. Comfort Theory: a unifying framework to enhance the practice environment. J Nurs Adm. 2006 Nov;36(11):538-44. doi: 10.1097/00005110-200611000-00010.
PubMed 17099440Kolcaba K, DiMarco MA. Comfort Theory and its application to pediatric nursing. Pediatr Nurs. 2005 May-Jun;31(3):187-94.
PubMed 16060582
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nursing Care Based on Kolcaba's Comfort Theory to the Comfort and Components of the Child and Parents Who Are Planned for Male Circumcision Operation
- ClinicalTrials.gov ID
- NCT04105556
- Acronym / sponsor ID
- Comfort Theory / SuleymanDUnursingcare
- Conditions
- Nursing Caries
- Keywords
- Male Child, Comfort Theory, Fear, Male Circimcision, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 26 Sep 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.
Aim: Male circumcision is one of the oldest and most commonly performed surgical procedures in the world and in our country. Circumcision, which concerns such a large population, is a stressful, traumatic, negative experience. Impairment in comfort is a condition in which a child who is scheduled for circumcision operation often suffers. Physical, emotional, sociocultural and environmental factors contribute to the formation of this condition. Comfort Theory is a nursing model that makes it easier for the caregivers to see their problems more systematically and to plan more easily. In the literature review, no studies have been found to determine the effect of nursing care based on Kolcaba Konfors Comfort Theory to the comfort and components of the children and their parents who have undergone circumcision operation. Therefore, this study was needed. In this study, nursing care based on Kolcaba's Comfort Theory, which continues throughout the perioperative period, was applied to children and their parents.
Method: In this study, the effect of nursing care based on Kolcaba's Comfort Theory on fear, anxiety, pain, comfort and anxiety in parents and health care satisfaction was tested in children. Care was given when the child and his / her parents applied to the outpatient clinic for anesthesia consultation on the working day before the operation, and care was continued in the day surgery unit. On the 1st and 3rd days after discharge, the researcher provided tele-monitoring and consultancy services. In addition, communication with the parents was maintained at all times as needed. Care was terminated on the 10th day after discharge. The time of the study was approximately 12-14 days for each child and his / her parents.
The sample of the study was determined as 120 boys and their parents (60 control each, 60 intervention each). In this study, standard nursing care will be applied to the control group and nursing care based on Kolcaba's Comfort Theory will be applied to the intervention group. The data will be collected with the Child and Family Descriptive, VAS, Children's State Anxiety (CSA) and Children's Fear Scale (CFS), Comfort Behavior Checklist, Spielberger State Anxiety Scale, PedsQL Health Care Satisfaction Scale.
Detailed description
In this study, nursing care based on Kolcaba's Comfort Theory, which continues throughout the perioperative period, was applied to children and their parents.
Care was given when the child and his / her parents applied to the outpatient clinic for anesthesia consultation on the working day before the operation, and care was continued in the day surgery unit. On the 1st and 3rd days after discharge, the researcher provided tele-monitoring and consultancy services. In addition, communication with the parents was maintained at all times as needed. Care was terminated on the 10th day after discharge. The time of the study was approximately 12-14 days for each child and his / her parents.
Nursing care consists of 3 types of comfort-oriented care interventions. These interventions;
- Standard maintenance interventions,
- Emotional focused comfort care interventions,
- Cognitive and functional comfort care interventions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Type of intervention, testing the comfort and components of children and parents of the circumcision operation plan with Nursing Care Based on Kolcaba's Comfort Theory
| Arm | Type | Receives |
|---|---|---|
| Nursing Care Based on Kolcaba's Comfort Theory | Experimental | Other: Nursing Care Based on Kolcaba's Comfort TheoryIn this study, nursing care based on Kolcaba's Comfort Theory, which continues throughout the perioperative period, was applied to children and their parents. Care was given when the child and his / her parents applied to the outpatient clinic for anesthesia consultation on the working day before the operation, and care was continued in the day surgery unit. On the 1st and 3rd days after discharge, the researcher provided tele-monitoring and consultancy services. In addition, communication with the parents was maintained at all times as needed. Care was terminated on the 10th day after discharge. The time of the study was approximately 12-14 days for each child and his / her parents. Nursing care consists of 3 types of comfort-oriented care interventions. These interventions; 1. Standard maintenance interventions, 2. Emotional focused comfort care interventions, 3. Cognitive and functional comfort care interventions. |
| Routine hospital schedule | No intervention | –The researcher sincerely answered all questions asked by the control group during the perioperative period. After the post-discharge post-tests, the control group was given a gift of medal of courage, a story book and a training booklet prepared for the parents after the policlinic control on the 10th postoperative day, and the training was given to the intervention group. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- The child is between the ages of 4-7
- No previous surgical experience of the child
- Lack of chronic disease, disability and developmental delay of the child
- The child or his / her parent does not have a special situation that causes difficulties in understanding and perception.
- Parent's ability to read and write in Turkish
Key exclusion criteria (2 listed)
- Child / parent who does not volunteer to participate in the study
- Children who are not cared for at least two relatives during the surgical procedure
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 |
|---|---|---|
| Nursing Care Based on Kolcaba's Comfort TheoryAlso: • Pre-surgical preparation program • Comfort-oriented care • Tele-monitoring and consultancyIn this study, nursing care based on Kolcaba's Comfort Theory, which continues throughout the perioperative period, was applied to children and their parents. | Other | Nursing Care Based on Kolcaba's Comfort Theory |
Primary outcome
Comfort Behaviors Checklist
Time frame: In two weeks
Comfort Behaviors Checklist was developed in 1989 by Kolcaba. Developed as a last resort, data collectors are used to rate a patient's apparent comfort. While not as desirable as actually asking a patient about his or her comfort, the instrument can fill a gap regarding data collection in comatose, very frail (as in terminal), or cognitively limited patients. Kolcaba and DiMarco (2005) reported that postoperative comfort in children can be assessed using the Comfort Behavior Checklist. The reliability and validity study of our country was conducted by Unutkan and Balcı Yangın (2018).
VAS
Time frame: In two weeks
The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. Instructions, time period for reporting, and verbal descriptor anchors have varied widely in the literatüre. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]). Varies, but most commonly respondents are asked to report "current" pain intensity or pain intensity "in the last 24 hours." A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm)
Children's Fear Scale
Time frame: In two weeks
It was developed by McMurty et al. (2011). The validity and reliability study of the Turkish Children's Fear Scale was conducted by Özalp Gerçeker and colleagues in 2017. The scale can be used to assess fear in children aged 4-10 years. The CFS consists of five drawn facial expressions ranging from neutral expression (0 = no anxiety) to the frightened face (4 = severe anxiety), and can be easily evaluated by parents, researchers, and healthcare professionals who care for the child. It is a scale of one item. CFS was developed based on the Faces Anxiety Scale developed to measure the anxiety or fear of adults in the intensive care unit of McKinley et al. (2003).
Children's Anxiety Meter-State (CAM-S)
Time frame: In two weeks
The scale was developed by Ersig et al. (2013). The Turkish validity and reliability study of the scale was conducted by Özalp Gerçeker et al. The scale can be used to assess anxiety in children aged 4-10 years. The score can vary from 0 to 10 (Ersig et al., 2013)
The State-Trait Anxiety Inventory (STAI)
Time frame: In two weeks
In the study, STAI will be used to determine the anxiety of parents. It was developed by Spielberger et al. (1970). The Turkish validity and reliability study of the STAI was conducted by Öner and Le Compte in 1983. The scale is a 4-point Likert type and contains two 20-item expressions. Direct expressions express negative emotions and reversed expressions express positive emotions. It was reported that the Cronbach Alpha internal consistency coefficient ranged between α = 0.83 and 0.87 (Sarıtaş and Büyükbayram, 2016).
The PedsQL (Pediatric Quality of Life InventoryTM)
Time frame: In two weeks
The PedsQL will be used to measure the level of health care satisfaction of parents. The scale consists of 25 questions. The questions in the scale are aimed at measuring satisfaction with medical care services and psychosocial satisfaction. Cronbach Alpha internal consistency coefficient of the scale, which was validated by Varni (1999), was found to be α = .96. Scale was adapted to Turkish by Ulus and Kublay (2012).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Background: PubMed 17004666Wagner D, Byrne M, Kolcaba K. Effects of comfort warming on preoperative patients. AORN J. 2006 Sep;84(3):427-48. doi: 10.1016/s0001-2092(06)63920-3.
- Background: PubMed 17627198Dowd T, Kolcaba K, Steiner R, Fashinpaur D. Comparison of a healing touch, coaching, and a combined intervention on comfort and stress in younger college students. Holist Nurs Pract. 2007 Jul-Aug;21(4):194-202. doi: 10.1097/01.HNP.0000280931.75883.ae.
- Background: PubMed 17381027Dowd T, Kolcaba K. Two interventions to relieve stress in college students. Beginnings. 2007 Winter;27(1):10-1. No abstract available.
- Background: PubMed 17099440Kolcaba K, Tilton C, Drouin C. Comfort Theory: a unifying framework to enhance the practice environment. J Nurs Adm. 2006 Nov;36(11):538-44. doi: 10.1097/00005110-200611000-00010.
- Results publication: PubMed 16060582Kolcaba K, DiMarco MA. Comfort Theory and its application to pediatric nursing. Pediatr Nurs. 2005 May-Jun;31(3):187-94.
- 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.
Emine EFE study director
Akdeniz Universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing Care Based on Kolcaba's Comfort Theory in people with Nursing Caries, run by Suleyman Demirel University 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 2 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: status not confirmed, as of the sponsor's last update on 26 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fahriye PAZARCIKCI, Res. Assist. (05052560327 ext. 05052560327, fahriyepazarcikci@sdu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comfort Behaviors Checklist (time frame: In two weeks). 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?
On the ClinicalTrials.gov record for NCT04105556, which also lists 5 linked publications.
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 26 Sep 2019.