Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT03167567 |
| Other study ID # |
0081-15-POR |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
May 23, 2017 |
| Last updated |
May 24, 2017 |
| Start date |
July 1, 2017 |
| Est. completion date |
June 30, 2018 |
Study information
| Verified date |
May 2017 |
| Source |
The Baruch Padeh Medical Center, Poriya |
| Contact |
Izhar Ben Shlomo, MD |
| Phone |
972-52-6124781 |
| Email |
ibenshlomo[@]poria.health.gov.il |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Women during their first labor will be offered the assistance of a medical clown. Their
experience will be compared after delivery with that of primiparae who were not helped by a
medical clown.
Description:
Introduction Midwives have been known for many years to give support, care and advice to
pregnant women during pregnancy, birth and after birth. The word midwife literally means
'with woman'. It is known that throughout the age's women during childbirth depended upon a
skilled person (usually a woman in the olden days). Her skill is based partly on art and
partly on science. Art: the ability to understand the woman's need, encourage and build her
confidence. Science: knowledge and decision-making. The midwife refrains from taking control
away from the mother, but is at hand to step in where assistance is needed (Myles 1999).
Literature review Labor is a normal physiological process, but is usually associated with
pain and discomfort. (Othman, Jones, & Neilson, 2012). Over the years, various measures to
relieve stress, discomfort, pain, fear and anxiety during labor have been explored. (Ganji,
shirvani, rezaei-Abhari, & Danesh, 2013). Therefore, these issues that impact the wellbeing
of the pregnant and laboring woman are of primary interest and value to caregivers.
(Bergstrom, Kieler, & Waldenstrom, 2009). However, many women would like to have a choice in
pain relief during labor and also would like to avoid invasive methods of pain management in
labor. (Klomp, van Poppel, Jones, Lazet, Di Nisio, & Lagro-Janssen, 2012). Adams,
Eberhard-Gran, and Eskild, (2012) concluded that duration of labor was longer in women with
fear of childbirth than in women without it. The search for supporting measures such as the
use of birthing in water, yoga, and other non invasive approaches in addition to drug
administration during labor is crucial.
Midwives support natural birth as much as possible. Thus, preparation classes have been
introduced to teach and enlighten pregnant woman, in order for them to understand the
changes and process of pregnancy, labor and after birth concerning their bodies. Stress,
depression, and anxiety affect 15 to 25% of pregnant women. However, fewer than 20% of
prenatal care providers assess and treat mental health problems and fewer than 20% of
pregnant women seek mental healthcare (Kingston. D. et al., 2014).
In The Baruch Pade Medical Center there are approximately 60 live births of primiparous
women monthly.
Medical clowning has been used as a supportive factor, mostly in pediatric settings
(Gorfinkle et al., 1998; Koller & Gryski, 2008; Scheyer et al., 2008). Medical clowns are
trained professionals (Bornstein, 2008; Hart, 2012) who master at least one of the various
stage arts such as theatre, acting, circus or puppetry. Their aim is to improve the mental
and physical well-being of patients by easing pain and anxiety due to hospitalization. The
clowns strive to be an integral part of the medical team and are even present during
physically intrusive procedures (Hart, 2012; Smerling et al., 1999; Tener, Lnag-Franco, Ofir
& Lev-Wiesel, 2012). The medical clown plays a therapeutic and a diagnostic role and is
perceived as any other paramedical therapist (Hart, 2012).
The medical clown uses a broad spectrum of verbal and non-verbal artistic tools including
mime, movement, play, act and music in order to create humor and an alternative, imaginative
safe reality (Nuttman-Schwartz, Scheyer & Tzioni, 2010). By doing so, the clown builds an
empowering and supportive relationship (Bornstein, 2008; Koller & Gryski, 2008 The empirical
data regarding medical clowns in hospitals is limited (e.g. Battrick, Glasper & Weaver,
2007; Bornstein, 2008; Weaver, Prudhome, Battrick & Glasper, 2007). However, the influence
of humor and laughter on decreasing anxiety levels while preparing for surgery, post
fertility treatments, children undergoing intra-articular corticosteroid injection, children
with special needs and sexually abused children has been studied (Fernandes & Arriaga, 2010;
Friedler et al., 2010; Higueras et al., 2006; Kingsnorth, Blain & McKeever, 2010; Koller &
Gryski, 2008; Tener et al., 2010, 2012; Oren-Ziv, Hanuka, Rotchild, Gluzman, & Uziel, 2012;
Vagnoli, Caprilli & Messeri, 2010; Vagnoli, Caprilli, Robiglio & Messeri, 2005). Additional
studies found that medical clowns are helpful both for health care providers (Smerling et
al., 1999) and patients (Battrick et al., 2007) with no difference between hospitalized
patients and outpatients (Scheyer et al., 2008; Weaver et al., 2007).
Medical clowns have been introduced into the hospital settings in the pediatric settings,
IVF, operating theaters, oncology, geriatrics and others with positive results shown
statistically. The benefits of medical clowning intervention, are in encouraging and
supporting patients to co-operate with treatment procedure, in reducing stress, coping with
fears, anxiety and reducing pain.
Extensive evidence indicates that negative and positive affective traits such as depression,
worry, calmness, or cheerfulness can influence physical health (Papousek & Schulter, 2008).
Also, There is strong evidence that positive and negative affects strongly influence
subjective physical health (such as symptom reporting, self rated health or perception of
the examinations performed) (Cohen, Doyle, Turner, Alper & Skoner, 2003; Cohen 1995; Hirdes
& Forbes, 1993; Watson & Pennebaker, 1989). An increase in the patient wellbeing could be
the result of an increase in positive affect, a decrease in negative affect, or a
combination of the two factors (Charles, Reynolds & Gatz, 2001). A number of methods are
used to induce positive moods and reduce negative affect in the experimental studies of mood
and health. In Pressman and Cohen (2005, 2006) review of 45 empirical studies about affect
and health, manipulations that involved active participation or were particularly engaging
to the participant were found to be more effective in influencing positive and negative
affect, whereas more passive manipulations failed to do so. Medical Clowns may be an active
and engaging way of enhancing the positive and reducing the negative affect regarding
primiparas.
In the delivery room there are women in different stages of labor that are anxious and
fearful. It is to be noted that medical clowns have been working at The Padeh Medical Center
for the past 10 years and the area is still expanding to different departments in the
hospital such as: high risk pregnancy, parents in the neonatal intensive care units (NICU)
and in the In Vitro fertilization (IVF) unit. In addition, following a meeting of women
undergoing IVF treatments and women hospitalized due to high risk pregnancies, we have been
contacted by several women who expressed their wish to have a medical clown present during
their delivery. With this enlightenment, we find it necessary to check if it is possible to
assist the birthing woman and her care givers in the labor room with medical clowning in the
birth process.
The purposes of this study are:
1. To study the effect of female medical clowns on relieving anxiety during labor
2. To document whether the use of medical clowning can reduce the time for use of pain
relievers and shorten the duration of labor.
Methods:
Before their first birth, while visiting the hospital, a questionnaire will be administered
to the women. This will be a Likert-type response scale ranging from 1 (Not at all) to 5
(the most) rated by the primiparas, examining the women's perception of incorporating
medical clowning in the labor process. After birth, PANAS Scales short questionnaires which
measure the positive and negative affect of the primiparas will be filled in by the women
within 48 hours after giving birth (Charles, Reynolds & Gatz, 2001; Watson & Clark, 1988).
In addition, we will record measures regarding the length of labor and at what stage/after
after entering the labor room women asked for analgesics, what kind of analgesics they asked
for, and when and what did they receive.
Patients:
Two hundred women, older than 18 years, at their first expected labor,100 as intervention
group and 100 as the control group.
1. A candidate who will arrive at The Padeh Medical Center will be approached by a midwife
or a doctor with information about the research and will be asked if she wishes to take
part.
2. According to the patients' request and to the clown's shift, the patients will be
recruited to either the control or the research group.
3. A research team member will inform the participants who will be allocated to the
intervention that they can, at any stage, ask the clown to leave the delivery room. In
addition, primiparas from both groups will be informed that they can at any stage ask
to be excluded from the research. All these will be also explicitly stated in the
consent form which she will sign. Each participant will receive a number and her
details will be kept and available to the staff members only.
4. The delivery room staff will guide the clown as to when to join the primipara in the
delivery room. The medical clown will enter the delivery room and stay with the woman
as long as she wishes (within the clown's shift of 3 hours).
5. After the delivery a member of the research team or a research assistant will fill in
the demographic questionnaire.
6. Within 48 hours after delivery the patient will fill in the PANAS questionnaire.
7. At the conclusion of all the above, all data regarding the delivery, drug usage and
length of labor, complications if any will be entered to the CRF with all other
patients' data.
Clowns:
The female medical clowns will be present in the delivery rooms for a shift of 3 hours twice
a week.
Research tools:
1. Likert-type scale questionnaire (appendix 1).
2. Demographic questionnaire for the primiparas. (Appendix 2)
3. The PANAS scale - brief measures of positive and negative affect (appendix 3). Will be
given to the research group.
4. The PANAS scale - brief measures of positive and negative affect (appendix 3). Will be
given to the control group.
5. Information from the reports of the labor department regarding the length of labor and
of the analgesics requested by (timing and kind) given to the women and any
complications will be documented.
Data analysis:
Data from the Likert-type scales questionnaire will be analyzed in order to capture the
perception of women before labor of introducing medical clowns during labor. Data from the
PANAS questionnaire will be analyzed. Negative and Positive affect will be assessed in
adapted scales. Separate Hierarchical Multiple Regression analyses will be conducted to
examine the influence of the medical clown in the two dependent variables: Positive and
Negative affect. In addition, we will try to understand what parameters from the demographic
questionnaire effect the primipara's reaction and co-operation with the medical clown during
labor.
Control of Potential Biases:
The research group will contain two medical clowns, a gynecologist and 2 RN midwifes from
the labor ward team who have almost no experience in working with medical clowns and has no
preconception about the issue.
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