Total Joint Replacement SurgeryNCT07832253
Positive Affirmations and Preoperative Anxiety
A study testing Guided imagery and positive affirmations in people with Total Joint Replacement Surgery and Preoperative Anxiety, run by Hackensack Meridian Health at 1 site in United States.
Trial summary
This study is a prospective, quasi-experimental design using a convenience sample. This study will include patients who are having total knee or total hip replacement surgery. Participants will be invited to complete an anxiety scale at the conclusion of the total joint replacement (TJR) education class, listen to a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Joint Replacement Surgery, Preoperative Anxiety
- What is being tested?
- Guided imagery and positive affirmations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 15 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for total knee replacement or total hip replacement at the study facility
- 18 years of age or older
- Speak and read English
- Have access to a smartphone, tablet, or computer
Who cannot join
- < 18 years of age
- Does not speak and read English
- Does not have access to a smartphone, tablet, or computer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
HMH Old Bridge Medical Center
Old Bridge, New Jersey, 08857
Paula O'Neill, MS, RN, HNB-BC, MEDSURG-BC, 732-324-3217, paula.oneill@hmhn.org
About this study
Official title: The Effect of Guided Imagery and Positive Affirmations on Preoperative Anxiety in Patients Scheduled for a Total Joint Replacement
This study is a prospective, quasi-experimental design using a convenience sample. This study will include patients who are having total knee or total hip replacement surgery. Participants will be invited to complete an anxiety scale at the conclusion of the total joint replacement (TJR) education class, listen to a guided imagery and positive affirmations recording once/day for three days prior to surgery, beginning on the third day before surgery and continuing to the day before their scheduled surgical procedure, listen to positive affirmations the morning of surgery in the preop area, and then complete an anxiety scale before entering the operating room.
- Being tested
- Guided imagery and positive affirmations
- Keywords
- pre-operative anxiety, joint replacement surgery, Guided Imagery, Positive Affirmations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided imagery and positive affirmationsBehavioural
Daily recordings for 3 days before surgery up until the morning of the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Guided imagery and positive affirmations | Experimental | Participants will listen to a guided imagery recording followed by positive affirmations (approximately 23:26 minutes in length) once/day beginning on the third day before surgery and ending on the day before surgery. On the day of the surgery, participants will only listen to positive affirmations. Receives: Behavioral: Guided imagery and positive affirmations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Facial Anxiety Scale
The 6 item Visual Facial Anxiety Scale (VFAS) is an emoji based tool used to measure preoperative anxiety. It utilizes 6 emoji faces that reflect levels of anxiety from none to high (corresponding to 0-10 scale, with 0 being no anxiety and 10 being the highest anxiety). .
The surveys are completed in the TJR education class, before listening to the guided imagery and positive affirmations, and after listening to positive affirmations, which is done in the preop area immediately before entering the operating room the day of surgery. The completion of the scale takes approximately 7-8 secs. Listening to the guided imagery and positive affirmation recordings takes 23:26 minutes, and listening to the positive affirmations on the day of surgery takes 3:11 minutes.
Measured: At baseline and immediately before entering the operating room on the day of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion15 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Joint Replacement SurgeryStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paula O'Neill, MS, RN, HNB-BC, MEDSURG-BC, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832253
- Sponsor's protocol ID
- Pro2026-0276
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Guided Imagery and Positive Affirmations on Preoperative Anxiety in Patients Scheduled for a Total Joint Replacement
- ClinicalTrials.gov ID
- NCT07832253
- Acronym / sponsor ID
- Pro2026-0276
- Keywords
- pre-operative anxiety, joint replacement surgery, Guided Imagery, Positive Affirmations
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 15 Jan 2028 (estimated)
- First posted
- 21 Sep 2026 (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.
This study is a prospective, quasi-experimental design using a convenience sample. This study will include patients who are having total knee or total hip replacement surgery. Participants will be invited to complete an anxiety scale at the conclusion of the total joint replacement (TJR) education class, listen to a guided imagery and positive affirmations recording once/day for three days prior to surgery, beginning on the third day before surgery and continuing to the day before their scheduled surgical procedure, listen to positive affirmations the morning of surgery in the preop area, and then complete an anxiety scale before entering the operating room.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Guided imagery and positive affirmations | Experimental | Behavioral: Guided imagery and positive affirmationsParticipants will listen to a guided imagery recording followed by positive affirmations (approximately 23:26 minutes in length) once/day beginning on the third day before surgery and ending on the day before surgery. On the day of the surgery, participants will only listen to positive affirmations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled for total knee replacement or total hip replacement at the study facility
- 18 years of age or older
- Speak and read English
- Have access to a smartphone, tablet, or computer
Key exclusion criteria (3 listed)
- < 18 years of age
- Does not speak and read English
- Does not have access to a smartphone, tablet, or computer
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 |
|---|---|---|
| Guided imagery and positive affirmationsDaily recordings for 3 days before surgery up until the morning of the surgery. | Behavioural | Guided imagery and positive affirmations |
Primary outcome
Visual Facial Anxiety Scale
Time frame: At baseline and immediately before entering the operating room on the day of the surgery
The 6 item Visual Facial Anxiety Scale (VFAS) is an emoji based tool used to measure preoperative anxiety. It utilizes 6 emoji faces that reflect levels of anxiety from none to high (corresponding to 0-10 scale, with 0 being no anxiety and 10 being the highest anxiety). . The surveys are completed in the TJR education class, before listening to the guided imagery and positive affirmations, and after listening to positive affirmations, which is done in the preop area immediately before entering the operating room the day of surgery. The completion of the scale takes approximately 7-8 secs. Listening to the guided imagery and positive affirmation recordings takes 23:26 minutes, and listening to the positive affirmations on the day of surgery takes 3:11 minutes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- 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.
Paula O'Neill, MS, RN, HNB-BC, MEDSURG-BC principal investigator
Hackensack Meridian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided imagery and positive affirmations in people with Total Joint Replacement Surgery and Preoperative Anxiety, run by Hackensack Meridian Health at 1 site in United States.
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 4 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: opening soon, as of the sponsor's last update on 21 Sep 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paula O'Neill, MS, RN, HNB-BC, MEDSURG-BC (732-324-3217, paula.oneill@hmhn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Facial Anxiety Scale (time frame: At baseline and immediately before entering the operating room on the day of 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 21 Sep 2026.