Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06081725 |
Other study ID # |
181/22 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 20, 2023 |
Est. completion date |
October 5, 2023 |
Study information
Verified date |
February 2024 |
Source |
University of Haifa |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Playful interactions have an important role in human sociality. During playful interactions,
two individuals continuously co-create an imaginary world together, such as playing roles in
an imaginary scene or co-creating synchronized movements together. Playful interactions are
characterized by an enhanced sense of flow and joy and have been associated with physical and
psychological well-being across the lifespan. This research team and others have shown that
playful interactions are particularly beneficial for the older population, which are at
higher risk of cognitive decline and social isolation. The overarching aim of this proposal
is to conduct an in-depth investigation of the effects of playful interactions, in older
population. Specifically the investigators will test the effect of short playful interaction
on cognitive measures, as well as social and affective indices, and compare them to a
non-playful interaction (such exercise class, or personal conversation).
Description:
Play is a crucial activity that supports human beings and animals throughout the life course,
and enables individuals to acquire and practice complex physical, cognitive and social and
contemplative skills. The term 'play' has many meanings; over the years, psychologists and
biologists have tried to define criteria for the identification of playful behavior.
Generally speaking, playful behavior is spontaneous and rewarding to the individual, as
players play for the sake of playing; it has no immediate utility beside the play itself (as
opposed to, for example, rule-governed competitive sports activities). The play occurs
outside ordinary reality, yet maintains a relation with it. Playful behavior consists of
actions or thoughts, expressed in novel combinations (such as when a parent takes the role of
a child); it is grounded in positive social exchanges, in which the individual is more
inclined to behave or think in a spontaneous and flexible way.
In the current study, the investigators will focus on a particular form of social
playfulness, termed improvised dramatic interactions (IDI), which plays a central role in
creative arts therapies and contemplative arts. IDI can occur on different levels, ranging
from non-verbal expressions such as emotions, gestures, and postures, to verbal
communication, which involve real-time dialogue and narrative progression. It is the act of
spontaneous co-creation which requires people to cooperate on a moment-to-moment basis in
order to keep playing. The participants continuously exchange, co-adapt, and co-create.
Accordingly, IDI is believed to present an ongoing challenge (and provide training) for
different aspects of executive functions and to powerfully trigger a multitude of
attentional, perceptual, and social processes. Studies of IDI conducted among younger
populations point to its tangible beneficial effects on certain aspects of mental health,
such as a reduction of depressive and anxiety symptoms and an enhancement of mood and
psychological well-being.
Given the potential of IDI to improve mental health, it is surprising that research on this
topic is still sparse; frequently, it lacks well matched control activities and underlying
mechanisms are not fully understood. In addition, most studies on improvised playful
interactions have focused on children, adolescents and young adults. In this study the
investigators aim to examine the beneficial effects of a short playful interaction on the
cognitive, social, and mood of older people. the investigators will examine changes in
indices of mood, mental health, social functioning, cognition compared to an active control
intervention. The study also aims to compare between online playful interactions to face to
face.
In addition, in the past two decades there has been a shift toward the development of
"tailor-made" interventions that fit individual needs and abilities. This trend is especially
important in aging, given increased variability in personality and cognitive and sensory
characteristics. In the current study, the investigators aim to investigate the mediating
role of personality traits and cognitive functions in connection to the beneficial effect of
playful interactions in aging.
The investigators hypnotized that playful interactions will induce greater effects on
emotional and social indices, as well as on executive functioning, compared to more familiar
social interactions. The investigators hypothesize that these effects will be found in older
populations. The effects of short-term playful interaction tasks as compared to the matched
social control condition will be preserved in the online format. Individuals' characteristics
and personality traits will influence the effects of the interaction on the dependent
variables.
Participants
80 participants (up to 95, considering attrition).
To detect a significant interaction between conditions and participant groups (ANOVA
within-between interactions with repeated measures as a proxy for MLM, with 4 groups, and 6
types of repeated measures), assuming a medium-small effect size (f2 = .20), and a
conservative estimate of correlation (r = .33), a sample size of at least 18 in each arm
group is required to achieve a power of 0.90, using GPower. The investigators will recruit 20
participants per group expecting attrition.
Procedure
1. The study will take place in six sites including assisted living facilities, community
centers and adults day centers in Israel.
2. Participants will be invited by the research assistance to take part in the study.
3. Participants who will be willing to take part in the study will meet with the research
team and will read and signed an informed consent form before participating in the
study.
4. Following the informed consent signing, base line measures will be collected (traits and
cognitive measures) (T0).
5. Following base line assessment participants will be randomly assigned to four arms. At
first, they will randomly assign to one of two conditions (online or face to face). The
interactions will be separated in a week. A random half of the two conditions of
participants (online and face t face) will be assigned to practice the playful
interaction at the first week and control interaction in the second week, whereas for
the other half this order will be reversed.
6. One designated experiment assigned each participant randomly to one of the two
interactions (playful or control), to keep the other experiments blind to the activity.
7. For each participant, separate interactions will be conducted by a different
experimenter.
8. These are the four arms:
- Playful interactions operationalized by dramatic improvisation techniques based on
verbal and non-verbal elements in face to face setting
- Playful interactions operationalized by dramatic improvisation techniques based on
verbal and non-verbal elements in online setting
- An active control condition that involves introductory conversation and movement
exercises in face to face setting in face to face setting
- An active control condition that involves introductory conversation and movement
exercises in face to face setting in online setting
9. The interventions will meet the following criteria: a) ease of implementation in an
online system; b) a short interaction between 15-20 minutes. Both interactions
incorporated bodily movement; however, the playful interaction encompassed elements of
co-creation, spontaneity, and innovation, whereas the control interaction adhered to a
more conventional and routine approach.
10. The online interactions will take place using the ZOOM video conference software under
laboratory conditions.
11. All interactions will be guided by graduate students of the Theatre department at the
university of Haifa or drama therapy students or theatre facilitator - the facilitators,
who are unfamiliar to the participants. One designated experiment assigned each
facilitator randomly to one of the two interactions (playful or control), to keep the
other experiments blind to the activity. The facilitators will be randomly assigned to
the different interactions, so that for each participants the separate interactions were
conducted by a different facilitator.
12. All interactions will be videoed recorded. A fidelity check will be done by the research
team every week to make sure each participants was given the correct interaction
(playful or control), and that each interaction included all phases in the protocol.
13. Both interactions will commence with a battery of tests and self-reports before (T1) and
after each session (T2). The battery of tests was conducted by an experimenter who will
be blind to the type of intervention (playful or control).
14. All self-reports and tests will be administered individually in a quiet and well-lighted
room before and after each activity. Items will be read aloud to participants when this
will be necessary, and responses will be given orally and coded by the researcher. At
the end of the initial assessment (T1), participants transitioned to a designated room,
equipped with a computer connected to Zoom, or in case of face to face interaction they
will meet the facilitator. They will be introduced to the facilitator previously unknown
to them and then the experimenter will leave (so they won't be able to know which
intervention will be delivered). Each interaction (playful or control) will be
administered by a different and unfamiliar experimenter.
15. At the end of the interaction, participants reconvene with the primary researcher for
the administration of the second assessment (T2). It is important to note that the
investigators will take pains to ensure that the experimenter administering the initial
and second assessment will be blind to the experimental condition.
Dependent variables
At base line (T0):
1. Cognitive tests: forward and backward digit span (WISC III, 1991), phonetic fluency
taken (Kave, 2005) from the Hebrew version of the WAIS-IV, ANT attention network test
(for younger adults), flanker task (for older adults).
2. Traits (openness to experience and extraversion), attachment styles, novelty seeking and
social anxiety will be assessed as control variables and for exploratory analysis to
investigate sub-populations for whom playful interactions are most beneficial.
Pre interaction (T1)
- Mood Post interaction (T2)
- Cognitive tests
- Mood
- Flow Questionnaire
- Subjective Arousal
- Closeness
- Perceived Partner Responsivness
- Freiburg Mindfulness Inventory
Data analysis
To test the effects of playful interactions in all of the above measures and experiments the
investigators use various tools. As the investigators do not wish to assume equality of
variance and a normal distribution, they will apply a mixed-level linear model (MLM). The
various measures (cognitive, social, and emotional measures) will serve as the dependent
variables; age group (young vs. older adults) and platform (online or F2F) as the
between-participant variables, and time of testing (before vs. after) and experimental
condition (playful interaction vs. control) as the repeated measures. Follow-up analyses will
attempt to find connections between the different dependent measures and relate it to the
different experimental groups, traits and age groups. This will be done in exploratory
mediation and moderation analyses as well as by correlation analysis