Improving vaccine-related pain, distress or fear in healthy children and adolescents–a systematic search of patient-focused interventions

Figures & data

Figure 1. Flowchart of study identified, screened and included.

Table 1. Summary of site-specific interventions.↑, variables significantly higher/greater in the specified group compared to other groups; ↔, no significant difference between groups; ↓, variables significantly lower in specified group compared to other groups.

Author	Year	Participants	Study design	Intervention	Vaccine	Self-report measures
Designed devices
Berberich et al.,	2009	N = 41	RCT	1) Control	MMR	Pain
		4–6 year olds		2) Distraction (Coolant, arm gripper and vibrating instrument)	DPT	Distraction ↓
					IVP
Sabiner et al.,	2015	N = 104	RCT	1) Control	DPT	Pain
		7 year olds		2) Buzzy (cooling and vibration device)		Buzzy ↓
Cooling
Abbott and Fowler-Kerry	1995	n = 90	RCT	1) No-spray control	DPT	Pain
		4–5.5 year olds		2) Placebo topical spray		Placebo ↓
				3) Refrigerant topical anaesthetic		Anaesthetic spray ↓
Gedaly-Duff & Burns	1992	n = 38	RCT	1) Typical Care	DPTP	Pain
		4–6 year olds		2) Ice (30 sec)	DT	↔
Cohen et al.,	2009	n = 57	RCT	1) Typical care	All routine vaccine	Pain
		4–6 year olds		2) Vapocoolant		Vapocoolant ↑
Eland	1981	N = 40	RCT	1) Vapocoolant	DPT	Pain
		4–5 year olds		2) Air Spray		Vapocoolant ↓
Topical anaesthetic
Cassidy et al.,	2001	n = 161	RCT	1) Placebo	DPTP	Pain
		4–6 year olds		2) EMLA		EMLA ↓
Cohen et al.,	1999	N = 39	RCT	1) EMLA	Hepatitis B	Pain
		8–11 year olds		2) Distraction (Nurse coaching and movie)		↔
				3) Typical care		Distress
						↔
Cohen et al.,	2001	N = 22	Latin Square	1) EMLA	Hepatitis B	Pain
		8–11 year olds		2) Distraction (Nurse coaching and movie)		↔
				3) Typical care		Distress
						↔
Tactile stimulation
Cobb & Cohen	2009	N = 89	RCT	1) Typical care	All routine vaccine	Pain
		4–12 year olds		2) Placebo		↔
				3) Shotblocker (small, flat u-shaped device, with rounded nubs to stimulate the skin around the site of injection)
Sparks	2001	N = 105	Quasi-experimental	1) Standard care	DPT	Pain
		4–6 year olds		2) Touch		Touch ↓
				3) Bubble blowing		Bubble ↓
						Fear
						↔

Table 2. Summary of patient-focused interventions.↑, variables significantly higher/greater in the specified group compared to other groups; ↔, no significant difference between groups; ↓, variables significantly lower in specified group compared to other groups.

Author	Year	Participants	Study design	Intervention	Vaccine	Self-report measures
Chewing gum
Lewkowski et al.,	2003	N = 115	RCT	1) Unsweetened gum pre	Hepatitis B	Pain
		9–11 year olds		2) Sweetened gum pre		↔
				3) Unsweetened gum pre + during
				4) Sweetened gum pre + during
Computerized devices
Burns-Nader et al.,	2016	N = 41	RCT	1) Distraction	Any Immunization	Pain
		4–11 year olds		2) no distraction		↑
Video (tv) watching
Cassidy et al.,	2002	N = 62	RCT	1) Watch TV	DPTP	Pain
		5 year olds		2) Watch blank TV screen		↔
Cerne et al.,	2015	N = 35	RCT	1) Standard care	DPT	Pain
		6 year olds		2) Watching Cartoon	IPV	↔
					MPRV
					Meningococcal C
Cohen et al.,	1997	N = 92	Alternatively assigned	1) Standard Care	DPT	Pain
		4–6 year olds		2) Nurse coach + TV	MMR	Nurse coach + TV ↓
				3) Nurse coach + TV + train parent and child		Nurse coach + TV + train ↓
Cohen et al.,	1999	N = 39	RCT	1) EMLA	Hepatitis B	Pain
		8–11 year olds		2) Distraction (Nurse coaching and movie)		↔
				3) Typical care		Distress
						↔
Cohen et al.,	2001	N = 22	Latin Square	1) EMLA	Hepatitis B	Pain
		8–11 year olds		2) Distraction (Nurse coaching and movie)		↔
				3) Typical care		Distress
						↔
Cohen et al.,	2015	N = 90	RCT	1) Control	DPTP	Pain
		4 – 6 year olds		2) Distraction only (laptop computers for adults – children watching + DVD watching during)	MMR Varicella	↔
				3) ‘Bear essentials’ + Distraction
Music
Fowler-Kerry & Lander	1987	N = 200,	RCT	1) Distraction (music with earphone)	DPT	Pain
		4–5.5 year olds		2) Suggestion (earphone without music)		Distraction ↓
				3) Distraction + Suggestion
				4) Control (with earphone)
				5) Control (without earphone)
			RCT
Kristjansdottir & Kristjansdottir,	2011	N = 118		1) Standard care	Polio	Pain
		13–15 year olds		2) Music distraction with headphones		Music ↓
				3) Music distraction without headphones		Without headphones ↓↓
Noguchi	2006	N = 64	RCT	1) Standard care	DPT	Pain
		4–6.5 year olds		2) Musical story	IVP	↔
				3) Spoken story	MMR
					Hepatitis A
					Hepatitis B
					Purified Protein Derivative
Positioning
Lacey et al.,	2008	n = 107	RCT	1) Supine position	MMR	Pain
		4–6 year olds		2) Sitting position	DPT	↔
					IVP	Fear
						Supine ↑
Breathing intervention
French et al.,	1994	N = 149	RCT	1) Expiration	DPT	Pain
		4 – 7 year olds		2) Typical care		↔
Manimala et al.,	2000	N = 82	RCT	1) Control	Routine Immunisation	Fear
		4–6 year olds		2) Parental reassurance		Distraction ↓
				3) Distraction (Party Blower)
Reis and Holubkov	1997	N = 62	RCT	1) EMLA + distraction	DPT	Pain
		4–6 year olds		2) Vapocoolant + distraction	MMR	Vapocoolant ↓
				3) Distraction (blowing pinwheel)	Varicella	Distress (1-min post)
						EMLA↓
						Vapocoolant ↓
						Distress (5 min post)
						↔
Sparks	2001	N = 105	Quasi-experimental	1) Standard care	DPT	Pain (Oucher)
		4–6 year olds		2) Touch		Touch ↓
				3) Bubble blowing		Bubble ↓
						Fear
						↔
Wallace et al.,	2010	N = 68	RCT	1) Control	DPT	Pain
		4–5 and 11–13 year olds		2) Cough	IPV	↔
					tetanus toxoid-reduced diphtheria
					toxoid-acellular pertussis
					meningococcal conjugate vaccines

Table 3. Summary of combined interventions.↑, variables significantly higher/greater in the specified group compared to other groups; ↔, no significant difference between groups; ↓, variables significantly lower in specified group compared to other groups.

Author	Year	Participants	Study design	Intervention	Vaccine	Self-reported measure
Boivin et al.,	2008	N = 239	Pseudo-randomized	1) Usual care	MMR	Pain
		4–12 year olds		2) Distraction (EMLA, child education, parental accompaniment, distraction with bubbles)	DPTDPTPHepatitis	Distraction ↓
Burgess et al.,	2015	N = 304–6 year olds	Retrospective, Quasi-experimental	1) Benzocaine based cooling spray + party blower (adult accompaniment)	Routine immunization	Pain↔Distress↓
Reis and Holubkov	1997	N = 62	RCT	1) EMLA + distraction	DPT	Pain
		4–6 year olds		2) Vapocoolant + distraction	MMR	Vapocoolant ↓
				3) Distraction (blowing pinwheel)	Varicella	Distress (1-min post)
						EMLA↓
						Vapocoolant ↓
						Distress (5 min post)
						↔

DT – Diptheria-tetanus.

DPT – Diphtheria-pertussis-tetanus.

DPTP – Diphtheria, pertussis, tetanus and polio immunization.

MMR – Measles, mumps, and rubella.

IVP – Inactivated poliovirus vaccine.

MPRV – Measles, mumps, rubella and varicella.

RCT – Randomized controlled trial.

Quasi-experimental – Non-randomized, pre- post- intervention.

Table 4. Summary of the Cochrane Collaborative Risk of Bias 5.1.0 tool. +, low risk of bias; −, high risk of bias; ?, unclear risk of bias.

	Cochrane Risk of Bias Version 5.1.0
	Random sequence generation.	Allocation concealment.	Blinding of participants and personnel	Blinding of outcome assessment (Self-reported)	Incomplete outcome data	Selective reporting.	Other sources of bias.	Overall risk of bias
Abbott & Fowler-Kerry, 1995	+	?	+	+	+	+	+	Unclear
Berberich et al., 2009	+	+	−	−	?	+	+	High
Boivin et al., 2008	−	−	−	−	−	+	+	High
Burns-Nader et al., 2016	+	?	−	−	?	+	+	High
Burgess et al., 2015	−	−	−	−	+	+	−	High
Cassidy et al., 2001	+	?	+	+	−	+	+	High
Cassidy et al., 2002	+	?	−	−	+	+	+	High
Cerne et al., 2014	+	?	−	−	+	+	+	High
Cobb & Cohen, 2009	+	+	+	+	+	+	−	High
Cohen et al., 1997	−	−	−	−	+	+	+	High
Cohen et al., 1999	+	?	−	−	−	+	+	High
Cohen et al., 2001	−	?	−	−	−	+	+	High
Cohen et al., 2009	+	+	−	−	+	+	−	High
Cohen et al., 2015	+	+	−	−	?	+	+	High
Eland, 1981	+	?	+	+	+	+	+	Unclear
Fowler-Kerry & Lander, 1987	+	?	−	−	+	+	+	High
French et al., 1994	+	−	−	−	−	+	+	High
Gedaly-Duff et al., 1992	+	?	−	−	−	+	+	High
Kristjansdottir & Kristjansdottir, 2010	+	?	−	+	−	+	+	High
Lacey et al., 2008	+	?	−	−	?	+	+	High
Lewkowski et al., 2003	+	?	+	+	?	+	+	Unclear
Manimala et al., 2000	+	−	−	−	?	+	+	High
Noguchi, 2006	+	?	+	+	?	+	−	High
Reis and Holubkov, 1997	+	?	−	−	+	+	+	High
Sabiner et al., 2015	+	?	−	−	+	+	+	High
Sparks, 2001	−	+	−	−	+	+	+	High
Wallace et al., 2010	+	?	−	−	?	+	+	High