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Trial · NCT07884435

Intervention Program for Psychological Well-Being in Institutionalized Older Adults Through Virtual Reality

NCT07884435, Not applicable, Recruiting, Francisco Antonio Nieto Escámez

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Intervention Program for Psychological Well-Being in Institutionalized Older Adults Through Virtual Reality. Trials, record NCT07884435. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07884435

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Intervention Program for Psychological Well-Being in Institutionalized Older Adults Through Virtual Reality
NCT number
NCT07884435
Status
Recruiting
Phases
Not applicable
Enrollment
60 participants, estimated
Lead sponsor
Francisco Antonio Nieto Escámez
Conditions
Healthy Volunteers, Aging, Healthy
Interventions
Active IVR Group, Passive IVR Goup
First posted
2026-10-20
Last updated
2026-11-02

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPositive and Negative Affect (I-PANAS-SF)Assessed at baseline (T0), immediately following each intervention session, and 1 week after completion of the intervention (T1).
Positive and negative affect will be assessed using the International Positive and Negative Affect Schedule Short Form (I-PANAS-SF). The questionnaire contains 10 items rated on a 5-point Likert scale and yields separate Positive Affect and Negative Affect subscale scores ranging from 5 to 25. Higher Positive Affect scores indicate greater positive affect, whereas higher Negative Affect scores indicate greater negative affect.
PrimaryAffect Balance (EBA)Assessed at baseline (T0), at the end of each intervention week (sessions 3, 6, 9, and 12), and 1 week after completion of the intervention (T1).
Affect balance will be assessed using the Affect Balance Scale (Escala de Balance Afectivo, EBA; Godoy-Izquierdo et al., 2008). The instrument contains 18 items rated on a 3-point Likert scale and comprises Positive Affect and Negative Affect subscales (9 items each). An Affect Balance Index is calculated by subtracting the Negative Affect score from the Positive Affect score, yielding a total score ranging from -18 to +18. Higher scores indicate a more positive affective balance, whereas lower scores indicate a predominance of negative affect.
PrimaryLife Satisfaction (SWLS)Assessed at baseline (T0) and 1 week after completion of the intervention (T1).
Life satisfaction will be assessed using the Satisfaction With Life Scale (SWLS). The instrument consists of 5 items rated on a 7-point Likert scale with visual support, yielding a total score ranging from 5 to 35. Higher scores indicate greater satisfaction with life.
PrimarySelf-Perceived Well-BeingAssessed immediately following each intervention session (12 sessions; IVR intervention groups only).
Self-perceived well-being will be assessed using a single-item numerical rating scale ranging from 1 to 10. Participants in the IVR intervention groups will rate their immediate post-session well-being. Higher scores indicate greater perceived well-being.
PrimaryState Anxiety (STAIr-State)Assessed at baseline (T0), immediately following each intervention session, and 1 week after completion of the intervention (T1).
State anxiety will be assessed using the State subscale of the short version of the State-Trait Anxiety Inventory (STAIr). The subscale consists of 6 dichotomous items, yielding scores ranging from 0 to 6. Higher scores indicate higher levels of state anxiety.
PrimaryTrait Anxiety (STAIr-Trait)Assessed at baseline (T0), immediately following each intervention session, and 1 week after completion of the intervention (T1).
Trait anxiety will be assessed using the Trait subscale of the short version of the State-Trait Anxiety Inventory (STAIr). The subscale consists of 7 dichotomous items, yielding scores ranging from 0 to 7. Higher scores indicate higher levels of trait anxiety.
SecondaryAcceptability of the Intervention (NPT-ES)Assessed immediately following each intervention session (12 sessions).
Acceptability of the intervention will be assessed using the adapted Non-Pharmacological Therapy Experience Scale (NPT-ES). This facilitator-rated scale consists of 5 items evaluating participation, pleasure, relationships with others, discomfort, and rejection, each rated on a 4-point scale (0-3). Item scores are summed to generate a total score ranging from 0 to 15, with higher scores indicating a more positive intervention experience and greater acceptability.
SecondaryParticipant Feedback on Virtual EnvironmentsAssessed immediately following each intervention session (12 sessions; IVR intervention groups only).
Participants in the immersive virtual reality intervention groups will complete an ad hoc 5-item questionnaire after each session. Responses are recorded as Yes/No and assess whether the virtual environments elicited feelings of excitement, calmness, discomfort, restlessness, and perceived realism.
OtherPost-Intervention Participant FeedbackOne week after the intervention (T1)
Post-intervention feedback will be collected from participants in the immersive virtual reality (IVR) groups using study-specific questionnaires administered 1 week after completion of the intervention. The questionnaires evaluate participants' perceptions of well-being associated with the IVR experience, including identification of the session types and virtual environments that generated the greatest sense of well-being. Responses include selection of preferred experiences and ratings of perceived well-being on a 1-10 scale.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
31829729BACKGROUNDPubMed
36758621BACKGROUNDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07884435

GET https://conductscience.org/api/trials/v1/NCT07884435/registered