Nurse-Patient RelationsNCT05169749
The Effect of Preoperative Nursing Visit on Anxiety and Pain Level of Patients After Surgery
A study testing Nursing Visiting Group in people with Nurse-Patient Relations, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
A nursing visit is a method used for psychological preparation and information of patients. During nursing visits, the operating room nurse visits the patient before the surgery, informs the patient about the surgical process and nursing care practices and gives education. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nurse-Patient Relations
- What is being tested?
- Nursing Visiting Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 1 Oct 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who were 18 years old and above
- who could speak Turkish and who were able to communicate
- underwent laparoscopic general surgery (such as laparoscopic cholecystectomy, colon, inguinal hernia, appendectomy, incisional hernia, sleeve gastrectomy) were included in the study.
Who cannot join
- Emergency and unplanned cases,
- patients transferred to the intensive care unit after surgery,
- patients with neurological or psychological problems were excluded from the research.
Trial locations and contacts
1 site in 1 country.
About this study
A nursing visit is a method used for psychological preparation and information of patients. During nursing visits, the operating room nurse visits the patient before the surgery, informs the patient about the surgical process and nursing care practices and gives education. The study was conducted to determine the effect of nursing visit before laparoscopic surgery on the anxiety and pain level of the patient in the postoperative period.
Read the detailed description
In this study, a structured education program was created, the visiting nurse was ensured to be the nurse who is involved in the patient's surgery, and the levels of anxiety and pain were evaluated according to objective criteria in the postoperative period on the patient group planned for laparoscopic surgery.
The study was conducted with 135 patients, 72 in the experimental group and 63 in the control group. The website https://www.randomlists.com/random-letters was used during the randomization of the patients. The patients were randomly assigned to the experimental and control groups according to their sequence numbers.
For the standardization of patient education, an education booklet was prepared in line with the literature, and the final version was prepared by consulting experts. The experimental group was educated by visits of the operating room nurse. The control group was educated by the service nurse. Data were collected with state-trait anxiety inventory and visual analog scale.
Visual analog scale (VAS)- The scale, which is used to evaluate the pain intensity, aims to explain the patient's pain in numbers. The scale requires the patient to score the pain as the absence of pain starting from 0 (zero) and unbearable pain to be evaluated over 10 (ten) points Spielberger State-Trait Anxiety Inventory - Anxiety inventory was developed by Spielberg et al. in 1970 and adapted into Turkish by Oner and Le Compte in 1977. This inventory is a four-degree Likert type scale ranging from "Almost never" to "Almost always". In the state anxiety scale, the individual evaluates how he/she feels "right now". The total score obtained from each scale varies between 20 and 80. A high score indicates a high anxiety level, a low score indicates a low anxiety level The State-Trait Anxiety Inventory was applied before the patient education and the State Anxiety Inventory after the education. The pain was monitored in accordance with the surgical patient follow-up protocol for 24 hours postoperatively, and the State Anxiety Inventory was applied again 24 hours after surgery.
- Conditions
- Nurse-Patient Relations
- Being tested
- Control-Service Nurse Group, Nursing Visiting Group
- Keywords
- Operating room nurse, Nursing visit, Laparoscopic surgery, Patient education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control-Service Nurse GroupProcedure or surgery
Processing Steps
- The State-Trait Anxiety Inventory was applied before the patient education
- The State Anxiety Inventory was applied after the education.
- The pain was monitored in accordance with the surgical patient follow-up protocol for 24 hours postoperatively
- The State Anxiety Inventory was applied again 24 hours after surgery.
Nursing Visiting GroupProcedure or surgery
Processing Steps
- The State-Trait Anxiety Inventory was applied before the patient education
- The State Anxiety Inventory was applied after the education.
- The pain was monitored in accordance with the surgical patient follow-up protocol for 24 hours postoperatively
- The State Anxiety Inventory was applied again 24 hours after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Control-Service Nurse Group | Other | Patient education lasting 20-30 minutes was provided by the nurse who gives care in the surgical inpatient floor before the surgery. The nurse provided the patient's admission to the postoperative surgical inpatient floor and follow-up. Receives: Procedure: Control-Service Nurse Group |
| Experimental-Nursing Visiting Group | Experimental | The nursing visit was done by the operating room nurse who will be involved in the patient's surgery, and the patient education lasted 20-30 minutes. The nurse, who carried out the nursing visit, welcomed the patient in the operating room, was next to the patient before anesthesia, and followed the patient to the recovery room after surgery. Receives: Procedure: Nursing Visiting Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in State Anxiety Level
State Anxiety Level is evaluated by Spielberger State-Trait Anxiety Inventory - This inventory is a four-degree Likert type scale ranging from "Almost never" to "Almost always". In the state anxiety scale, the individual evaluates how he/she feels "right now". The total score obtained from each scale varies between 20 and 80. A high score indicates a high anxiety level, a low score indicates a low anxiety level. Before, the patient education (before surgery) After, the education (before surgery) 24 hours after surgery.
Measured: Baseline to 24 hours postoperative
Change in Pain Score
Pain score is evaluated by Visual analog scale (VAS). The scale, which is used to evaluate the pain intensity, aims to explain the patient's pain in numbers. The scale requires the patient to score the pain as the absence of pain starting from 0 (zero) and unbearable pain to be evaluated over 10 (ten) points. Immediately after surger: Every 1 hour and 15 minutes after being admitted to the surgical inpatient floor (15 minutes-30 minutes-45 minutes-60 minutes), every next 2 hours and 30 minutes (90 mins-120 mins-150 mins-180 mins), every next 4 hours (4th-5th-6th-7th hour), every next 4 hours (11th-15th-19th-24th hours). Data were collected between the zero and 24 hours.
Measured: Baseline to 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start1 Mar 2019
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Nurse-Patient RelationsStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Uslu, Acibadem University
- Investigators
- Yasemin Uslu, Asisst Prof, Principal investigator, Acıbadem Mehmet Ali Aydınlar Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169749
- Sponsor's protocol ID
- ATADEK 2018-16/33
- Status last verified
- Dec 2021
- First submitted
- 29 Nov 2021
- Last updated
- 27 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carter L, Evans T. Preoperative visiting: a role for theatre nurses. Br J Nurs. 1996 Feb 22-Mar 13;5(4):204, 206-7. doi: 10.12968/bjon.1996.5.4.204.
PubMed 8704447Coll AM, Ameen JR, Mead D. Postoperative pain assessment tools in day surgery: literature review. J Adv Nurs. 2004 Apr;46(2):124-33. doi: 10.1111/j.1365-2648.2003.02972.x.
PubMed 15056325Guo P, East L, Arthur A. A preoperative education intervention to reduce anxiety and improve recovery among Chinese cardiac patients: a randomized controlled trial. Int J Nurs Stud. 2012 Feb;49(2):129-37. doi: 10.1016/j.ijnurstu.2011.08.008. Epub 2011 Sep 22.
PubMed 21943828Marcus C. Strategies for improving the quality of verbal patient and family education: a review of the literature and creation of the EDUCATE model. Health Psychol Behav Med. 2014 Jan 1;2(1):482-495. doi: 10.1080/21642850.2014.900450. Epub 2014 Apr 28.
PubMed 25750796Sadati L, Pazouki A, Mehdizadeh A, Shoar S, Tamannaie Z, Chaichian S. Effect of preoperative nursing visit on preoperative anxiety and postoperative complications in candidates for laparoscopic cholecystectomy: a randomized clinical trial. Scand J Caring Sci. 2013 Dec;27(4):994-8. doi: 10.1111/scs.12022. Epub 2013 Jan 28.
PubMed 23350886Aydal P, Uslu Y, Ulus B. The Effect of Preoperative Nursing Visit on Anxiety and Pain Level of Patients After Surgery. J Perianesth Nurs. 2023 Feb;38(1):96-101. doi: 10.1016/j.jopan.2022.05.086. Epub 2022 Aug 13.
PubMed 35970660
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Nursing Visit on Anxiety and Pain Level of Patients After Surgery
- ClinicalTrials.gov ID
- NCT05169749
- Acronym / sponsor ID
- ATADEK 2018-16/33
- Conditions
- Nurse-Patient Relations
- Keywords
- Operating room nurse, Nursing visit, Laparoscopic surgery, Patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 27 Dec 2021 (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.
A nursing visit is a method used for psychological preparation and information of patients. During nursing visits, the operating room nurse visits the patient before the surgery, informs the patient about the surgical process and nursing care practices and gives education. The study was conducted to determine the effect of nursing visit before laparoscopic surgery on the anxiety and pain level of the patient in the postoperative period.
Detailed description
In this study, a structured education program was created, the visiting nurse was ensured to be the nurse who is involved in the patient's surgery, and the levels of anxiety and pain were evaluated according to objective criteria in the postoperative period on the patient group planned for laparoscopic surgery.
The study was conducted with 135 patients, 72 in the experimental group and 63 in the control group. The website https://www.randomlists.com/random-letters was used during the randomization of the patients. The patients were randomly assigned to the experimental and control groups according to their sequence numbers.
For the standardization of patient education, an education booklet was prepared in line with the literature, and the final version was prepared by consulting experts. The experimental group was educated by visits of the operating room nurse. The control group was educated by the service nurse. Data were collected with state-trait anxiety inventory and visual analog scale.
Visual analog scale (VAS)- The scale, which is used to evaluate the pain intensity, aims to explain the patient's pain in numbers. The scale requires the patient to score the pain as the absence of pain starting from 0 (zero) and unbearable pain to be evaluated over 10 (ten) points Spielberger State-Trait Anxiety Inventory - Anxiety inventory was developed by Spielberg et al. in 1970 and adapted into Turkish by Oner and Le Compte in 1977. This inventory is a four-degree Likert type scale ranging from "Almost never" to "Almost always". In the state anxiety scale, the individual evaluates how he/she feels "right now". The total score obtained from each scale varies between 20 and 80. A high score indicates a high anxiety level, a low score indicates a low anxiety level The State-Trait Anxiety Inventory was applied before the patient education and the State Anxiety Inventory after the education. The pain was monitored in accordance with the surgical patient follow-up protocol for 24 hours postoperatively, and the State Anxiety Inventory was applied again 24 hours after surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control-Service Nurse Group | Other | Procedure: Control-Service Nurse GroupPatient education lasting 20-30 minutes was provided by the nurse who gives care in the surgical inpatient floor before the surgery. The nurse provided the patient's admission to the postoperative surgical inpatient floor and follow-up. |
| Experimental-Nursing Visiting Group | Experimental | Procedure: Nursing Visiting GroupThe nursing visit was done by the operating room nurse who will be involved in the patient's surgery, and the patient education lasted 20-30 minutes. The nurse, who carried out the nursing visit, welcomed the patient in the operating room, was next to the patient before anesthesia, and followed the patient to the recovery room after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who were 18 years old and above
- who could speak Turkish and who were able to communicate
- underwent laparoscopic general surgery (such as laparoscopic cholecystectomy, colon, inguinal hernia, appendectomy, incisional hernia, sleeve gastrectomy) were included in the study.
Key exclusion criteria (3 listed)
- Emergency and unplanned cases,
- patients transferred to the intensive care unit after surgery,
- patients with neurological or psychological problems were excluded from the research.
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 |
|---|---|---|
| Control-Service Nurse GroupProcessing Steps * The State-Trait Anxiety Inventory was applied before the patient education * The State Anxiety Inventory was applied after the education. * The pain was monitored in accordance with the surgical patient follow-up protocol for 24 hours postoperatively * The State Anxiety Inventory was applied again 24 hours after surgery. | Procedure or surgery | Control-Service Nurse Group |
| Nursing Visiting GroupProcessing Steps * The State-Trait Anxiety Inventory was applied before the patient education * The State Anxiety Inventory was applied after the education. * The pain was monitored in accordance with the surgical patient follow-up protocol for 24 hours postoperatively * The State Anxiety Inventory was applied again 24 hours after surgery. | Procedure or surgery | Experimental-Nursing Visiting Group |
Primary outcome
Change in State Anxiety Level
Time frame: Baseline to 24 hours postoperative
State Anxiety Level is evaluated by Spielberger State-Trait Anxiety Inventory - This inventory is a four-degree Likert type scale ranging from "Almost never" to "Almost always". In the state anxiety scale, the individual evaluates how he/she feels "right now". The total score obtained from each scale varies between 20 and 80. A high score indicates a high anxiety level, a low score indicates a low anxiety level. Before, the patient education (before surgery) After, the education (before surgery) 24 hours after surgery.
Change in Pain Score
Time frame: Baseline to 24 hours postoperative
Pain score is evaluated by Visual analog scale (VAS). The scale, which is used to evaluate the pain intensity, aims to explain the patient's pain in numbers. The scale requires the patient to score the pain as the absence of pain starting from 0 (zero) and unbearable pain to be evaluated over 10 (ten) points. Immediately after surger: Every 1 hour and 15 minutes after being admitted to the surgical inpatient floor (15 minutes-30 minutes-45 minutes-60 minutes), every next 2 hours and 30 minutes (90 mins-120 mins-150 mins-180 mins), every next 4 hours (4th-5th-6th-7th hour), every next 4 hours (11th-15th-19th-24th hours). Data were collected between the zero and 24 hours.
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 27 Dec 2021.
- Results publication: PubMed 8704447Carter L, Evans T. Preoperative visiting: a role for theatre nurses. Br J Nurs. 1996 Feb 22-Mar 13;5(4):204, 206-7. doi: 10.12968/bjon.1996.5.4.204.
- Results publication: PubMed 15056325Coll AM, Ameen JR, Mead D. Postoperative pain assessment tools in day surgery: literature review. J Adv Nurs. 2004 Apr;46(2):124-33. doi: 10.1111/j.1365-2648.2003.02972.x.
- Results publication: PubMed 21943828Guo P, East L, Arthur A. A preoperative education intervention to reduce anxiety and improve recovery among Chinese cardiac patients: a randomized controlled trial. Int J Nurs Stud. 2012 Feb;49(2):129-37. doi: 10.1016/j.ijnurstu.2011.08.008. Epub 2011 Sep 22.
- Results publication: PubMed 25750796Marcus C. Strategies for improving the quality of verbal patient and family education: a review of the literature and creation of the EDUCATE model. Health Psychol Behav Med. 2014 Jan 1;2(1):482-495. doi: 10.1080/21642850.2014.900450. Epub 2014 Apr 28.
- Results publication: PubMed 23350886Sadati L, Pazouki A, Mehdizadeh A, Shoar S, Tamannaie Z, Chaichian S. Effect of preoperative nursing visit on preoperative anxiety and postoperative complications in candidates for laparoscopic cholecystectomy: a randomized clinical trial. Scand J Caring Sci. 2013 Dec;27(4):994-8. doi: 10.1111/scs.12022. Epub 2013 Jan 28.
- Derived from this study: PubMed 35970660Aydal P, Uslu Y, Ulus B. The Effect of Preoperative Nursing Visit on Anxiety and Pain Level of Patients After Surgery. J Perianesth Nurs. 2023 Feb;38(1):96-101. doi: 10.1016/j.jopan.2022.05.086. Epub 2022 Aug 13.
- 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.
Yasemin Uslu, Asisst Prof principal investigator
Acıbadem Mehmet Ali Aydınlar Üniversitesi
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 Visiting Group in people with Nurse-Patient Relations, run by Acibadem 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 3 inclusion and 3 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 27 Dec 2021. 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?
Change in State Anxiety Level (time frame: Baseline to 24 hours postoperative). The study lists 2 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 NCT05169749, which also lists 6 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 27 Dec 2021.