Table 1.
Characteristics of the included studies.
| Study ID | Author (Year) | Country | Center | Procedure (Sample Size) | Age (Year) | IRB | Fund | Design | Type of Intervention (Characteristics) |
Control | Outcome | Quality Assessment |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | Canbulat et al. (2014) | Turkey | 1 hospital | Phlebotomy (n = 126), E: 63, C: 63 | 7–11 (8.8 ± 1.5) | Yes | Yes | RCT | Visual distraction (distraction cards) | No intervention | Pain: WB-FACES, Anxiety: CFS | 9 |
| 2 | Canbulat et al. (2014) | Turkey | 1 hospital | Phlebotomy (n= 125), E: 62, C: 63 | 7–11 (8.8 ± 1.5) | Yes | Yes | RCT | Visual distraction (Kaleidoscope) |
No intervention | Pain: WB-FACES (0–10), Anxiety: CFS (0–4) | 9 |
| 3 | Hsieh et al. (2017) | Taiwan | 1 hospital | IV (n = 68), E: 35, C: 33 | 6–12 (E:8.3 ± 1.6, C:7.8 ± 1.5) | Yes | No | Quasi | Cognitive-behavioral program (pre: Educational photo book 10–15 min, during: Favorite music video 5–10 min (40–60 dB)) |
Routine care | Pain: NRS (0–10) | 9 |
| 4 | Rimon et al. (2016) | Israel | 1 hospital | IV (n = 53), E: 29, C: 24 | 2–15 (E:5.6 ± 2.8, C:6.9 ± 3.4) | No | Yes | RCT | Medical clown (pre: Distraction via humor, during: Distraction via humor 15 min) | Parent regular distraction and comfort | Pain: VAS, FPS-R, S-cortisol | 7 |
| 5 | Kuo et al. (2016) | Taiwan | 1 medical center | IV (n = 184), E: 92, C: 92 | 3–7 (E:4.5, C: 4.51) | Yes | No | RCT | Visual distraction (story book reading) | Oral instruction | OSBD-R (1–4) | 8 |
| 6 | Kuo et al. (2016) | Taiwan | 1 medical center | IV (n = 184), E: 92, C: 92 | 3–7 (E:4.5, C:4.51) | Yes | No | RCT | Visual distraction (cartoon viewing (iPad)) | Oral instruction | OSBD-R (1–4) | 8 |
| 7 | Sahiner and Bal (2016) | Turkey | 1 hospital | Phlebotomy (n = 60), E: 30, C: 30 | 6–12 (9.1 ± 1.6) | Yes | No | RCT | Visual distraction (distraction cards) | Routine care | Pain: WB-FACES, Anxiety: CFS | 11 |
| 8 | Sahiner and Bal (2016) | Turkey | 1 hospital | 60 children for Phlebotomy (n = 60), E: 30, C: 30 | 6–12 (9.1 ± 1.6) | Yes | No | RCT | Audial distraction (music playback) | Routine care | Pain: WB-FACES, Anxiety: CFS | 11 |
| 9 | Sahiner and Bal (2016) | Turkey | 1 hospital | Phlebotomy (n = 60), E: 30, C: 30 | 6–12 (9.1 ± 1.6) | Yes | No | RCT | Touch distraction (balloon inflation) | Routine care | Pain: WB-FACES, Anxiety: CFS | 11 |
| 10 | Miller et al. (2016) | Australia | 1 hospital | IV (n = 40), E: 20, C: 20 | 3–12 (E:8.1 ± 3.0, C:7.0 ± 2.3) | Yes | No | RCT | Visual distraction (PSP: Sony handheld PSP, age- appropriate games) | Standard distraction | Pain: WB-FACES, VAS (0–10), FLACC (0–10) | 11 |
| 11 | Miller et al. (2016) | Australia | 1 hospital | IV (n = 40), E: 20, C: 20 | 3–12 (E:8.1 ± 3.0, C:6.4 ± 2.9) | Yes | No | RCT | Multisensory stimuli (animated visual content, sound) and vibration; Ditto-D: PSP + interactive games) | Standard distraction | Pain: WB-FACES, VAS (0–10), FLACC (0–10) | 11 |
| 12 | Miller et al. (2016) | Australia | 1 hospital | IV (n = 39), E: 19, C: 20 | 3–12 (E: 8.1 ± 3.0, C: 6.2 ± 2.8) | Yes | No | RCT | Multisensory stimuli (animated visual content, sound) and vibration; Ditto-PP: interactive procedural preparation story) | Standard distraction | Pain: WB-FACES, VAS (0–10), FLACC (0–10) | 11 |
| 13 | Miller et al. (2016) | Australia | 1 hospital | IV (n = 39), E: 19, C: 20 | 3–12 (E:8.1 ± 3.0, C:6.0 ± 2.3) | Yes | No | RCT | Multisensory stimuli (animated visual content, sound) and vibration; Ditto-C: story + interactive stories and games) | Standard distraction | Pain: WB-FACES, VAS (0–10), FLACC (0–10) | 11 |
| 14 | Sadeghi et al. (2018) | Iran | 1 hospital | IV (n = 60), E: 30, C: 30 | 4-6 | No | Yes | Quasi | Touch distraction (press a soft ball with the opposite hand | No intervention | Pain: WB-FACES | 7 |
| 15 | Aydin et al. (2016) | Turkey | 1 hospital | Phlebotomy (n = 60), E: 30, C: 30 | 7–12 (E:9.3 ± 1.8, C:9.9 ± 2.0) | Yes | No | RCT | Visual distraction (distraction cards) | Routine care | Pain: WB-FACES, Anxiety: CFS | 9 |
| 16 | Aydin et al. (2016) | Turkey | 1 hospital | Phlebotomy (n = 60), E: 30, C: 30 | 7–12 (E:9.7 ± 2.2, C:9.9 ± 2.0) | Yes | No | RCT | Touch distraction (soft ball) | Routine care | Pain: WB-FACES, Anxiety: CFS | 9 |
| 17 | Aydin et al. (2016) | Turkey | 1 hospital | Phlebotomy (n = 60), E: 30, C: 30 | 7–12 (E:9.7 ± 2.4, C:9.9 ± 2.0) | Yes | No | RCT | Touch distraction (balloon inflation) | Routine care | Pain: WB-FACES, Anxiety: CFS | 9 |
| 18 | Pour et al. (2017) | Iran | 2 hospital | Phlebotomy (n = 80), E: 40, C: 40 | 6–12 (8.0 ± 1.8) | Yes | No | RCT | Local anesthesia (2g EMLA cream, 45 min) | Routine care | Pain: FLACC (0–10) | 8 |
| 19 | Pour et al. (2017) | Iran | 2 hospital | Phlebotomy (n = 80), E: 40, C: 40 | 6–12 (8.0 ± 1.8) | Yes | No | RCT | Acupressure (Yintang (extra 1) and Laogong (P-8)) | Routine care | Pain: FLACC (0–11) | 8 |
| 20 | McCarthy et al. (2014) | USA | 3 hospitals | IV (n = 232), E: 116, C: 116 | 4–10 (7.3 ± 1.9) | Yes | Yes | RCT | Visual distraction (enhanced: RA distraction coaching) | Patent directed distraction | Pain: Oucher (0–10), PRCD (1–7), OSBD-R (1–4), Salivary cortisol | 8 |
| 21 | McCarthy et al. (2014) | USA | 3 hospitals | IV (n = 240), E: 124, C: 116 | 4–10 (7.3 ± 1.9) | Yes | Yes | RCT | Visual distraction (professional: RA distraction support) | Patent directed distraction | Pain: 23 Oucher 24 (0–10), PRCD25 (1–7), OSBD-26R (1–4), Salivary cortisol | 8 |
| 22 | Hillgrove-Stuart et al. (2013) | Canada | 1 clinic | IV (n = 66), E: 32, C: 34 | 1–2 (1.3 ± 0.2) | Yes | Yes | RCT | Touch distraction (parent directed distraction) | Routine care | Pain: M29BPS (0–10), 30MAISD | 11 |
| 23 | Hillgrove-Stuart et al. (2013) | Canada | 1 clinic | IV (n = 67), E: 33, C: 34 | 1–2 (1.3 ± 0.2) | Yes | Yes | RCT | Touch distraction (RA directed distraction) | Routine care | Pain: MBPS (0–10), MAISD | 11 |
| 24 | Cohen et al. (2015) | USA | 1 hospital | Immunization (n = 60), E: 30, C: 30 | 4–6.5 (4.8 ± 0.8) | Yes | Yes | RCT | Visual distraction (age- appropriate movie+ parent teaching program) | Routine care | Pain: CAPS, parent knowledge, parent behavior, children behavior | 11 |
| 25 | Cohen et al. (2015) | USA | 1 hospital | Immunization (n = 60), E: 30, C: 30 | 4–6.5 (4.8 ± 0.8) | Yes | Yes | RCT | Visual distraction+ education (age-appropriate movie) | Routine care | Pain: CAPS, parent knowledge, parent behavior, children behavior | 11 |
| 26 | Inal and Kelleci (2012) | Turkey | 1 hospital | IV (n = 123), E: 61, C: 62 | 6–12 (E:9.4 ± 2.1, C:9.3 ± 1.8) | Yes | No | RCT | Visual distraction (distraction cards) | Routine care | Pain: CAPS (0–5), FPS (0–10), anxiety | 12 |
| 27 | Jibb et al. (2018) | Canada | 1 hospital | SCP needle insertion for chemo (EMLA 60 min) (n = 39), E: 18, C: 21 | 4–9 (E:6.3 ± 1.4, C:6.1 ± 1.5) | Yes | Yes | RCT | Web-based service cognitive-behavioral program (MEDiPORT humanoid robot) | Active distraction robot with dancing and singing | Pain: FPS, NRS (0–10), fear: CFS (0–10), distress: BAADS (1–5) | 9 |
| 28 | Kristja and Kristja (2011) | Canada | 1 school | Immunization (n = 77), E: 38, C: 39 | 13–15 (14 ± 0.18) | Yes | No | RCT | Audial distraction (musical distraction: With headphone) | Standard care | Pain: VAS (0–10), anxiety, fear (0–10) | 7 |
| 29 | Kristja and Kristja (2011) | Canada | 1 school | Immunization (n = 80), E: 41, C: 39 | 13–15 (14 ± 0.18) | Yes | No | RCT | Audial distraction (musical distraction: without headphone) | Standard care | Pain: VAS (0–10), anxiety, fear (0–10) | 7 |
| 30 | Nilsson et al. (2015) | Sweden | 3 school | HPV vaccination (n = 37), E: 37, C: 37 | 11–12 | Yes | Yes | Crossover RCT | Visual distraction (relaxation and guided imagery) | Standard care | Pain: CAS (0–10), FAS (0.04–0.97), salivary cortisol | 10 |
| 31 | Oliveira et al. (2016) | Brazil | 1 hospital | IV (n = 40), E: 22, C: 18 | 6–12 (E:8.3 ± 2.1, C:8.7 ± 1.8) | Yes | No | Crossover RCT | Audiovisual distraction (Disney movie) | Routine care | Pain: VAS (0–10), FPS (0–10), PCS-C (13 item, 1–5), CSS (35 item, 0–4) | 8 |
| 32 | Hartling et al. (2013) | Canada | 1 hospital | IV (n = 42), E: 21, C: 21 | 3–11 | Yes | Yes | RCT | Audial distraction (musical distraction: with headphone) | Standard care | Pain: FPS-R (0–10), OSBD-R, anxiety | 10 |
| 33 | Redfern et al. (2018) | USA | 1 hospital | Vaccination (n = 50), E: 25, C: 25 | 3–18 (E:10.7 ± 4.7, C:10.5 ± 4.7) | Yes | No | RCT | Visual distraction (distraction cards) | No intervention | Pain: WB-FACES, parent satisfaction (0–10) | 12 |
| 34 | Risaw et al. (2017) | India | 1 hospital | Phlebotomy (n = 210), E: 105, C: 105 | 4–6 (4.8 ± 0.8) | Yes | No | RCT | Visual distraction (distraction cards) | Standard care | Pain: FLACC (0–10) | 10 |
| 35 | Bergomi et al. (2018) | Italy | 1 hospital | IV (n = 75), E: 36, C: 39 | 5–12 (E:8.3 ± 2.2, C:9.4 ± 2.3) | Yes | No | RCT | Touch distraction (BUZZY device) | Standard care | Pain: WB-FPS, CEMS, parent anxiety: NRS (0–10) | 7 |
| 36 | Bergomi et al. (2018) | Italy | 1 hospital | IV (n = 76), E: 37, C: 39 | 5–12 (E:9.4 ± 2.0, C:9.4 ± 2.3) | Yes | No | RCT | Visual distraction (cartoon) | Standard care | Pain: WB-FPS, CEMS, parent anxiety: NRS (0–10) | 7 |
| 37 | Bergomi et al. (2018) | Italy | 1 hospital | IV (n = 77), E: 38, C: 39 | 5–12 (E:8.6 ± 2.1, C:9.4 ± 2.3) | Yes | No | RCT | Touch distraction (BUZZY device + cartoon) | Standard care | Pain: WB-FPS, CEMS, parent anxiety: NRS (0–10) | 7 |
| 38 | Meiri et al. (2016) | Israel | 1 hospital | IV (n = 66), E: 33, C: 33 | 2–10 (E:5.4 ± 2.6, C:5.5 ± 2.6) | Yes | Yes | RCT | Medical clown (medical clown) | Standard care | Pain: VAS (0–10), anxiety (0–10), crying time | 7 |
| 39 | Meiri et al. (2016) | Israel | 1 hospital | IV (n = 67), E: 34, C: 33 | 2–10 (E:5.0 ± 2.4, C:5.5 ± 2.6) | Yes | Yes | RCT | Local anesthesia (EMLA cream, 50min) | Standard care | Pain: VAS (0–10), anxiety (0–10), crying time | 7 |
| 40 | Karakaya and Duygu G€ozen (2016) | Turkey | 1 hospital | IV (n = 144), E: 72, C: 72 | 7–12 | Yes | No | RCT | Visual distraction (kaleidoscope) | No intervention | Pain: FPS (0–10), pulse oximeter, thermometer | 7 |
| 41 | Cerne et al. (2014) | Italy | 1hospital | Immunization (n = 35), E: 18, C: 17 | 6 | Yes | No | RCT | Audiovisual distraction (cartoon movie) | Standard care | Pain: WB-FACES Distress: OSBD-A | 8 |
| 42 | Vagnoli et al. (2015) | Italy | 1hospital | Phlebotomy (n = 50), E: 25, C: 25 | 4–11 (E:7.1 ± 1.8, C:7.38 ± 2.5) | Yes | No | RCT | Visual distraction (dog presence) | Standard care | Pain: WB-FACES Distress: OSBD-A | 10 |
| 43 | Singh (2012) | India | 1hospital | Immunization (n = 60), E: 30, C: 30 | 1.5–2 | No | No | Quasi | Touch distraction (toy) | Standard care | Pain: FLACC (0–10) | 5 |
| 44 | Singh (2012) | India | 1hospital | Immunization (n = 60), E: 30, C: 30 | 1.5–2 | No | No | Quasi | Audial distraction (musical distraction) | Standard care | Pain: FLACC (0–10) | 5 |
| 45 | Minute et al. (2012) | Italy | 1hospital | Immunization (n = 97), E: 47, C: 50 | 4–10 (median: 7) | Yes | No | RCT | Visual distraction (Wii videogame+ EMLA cream) | EMLA cream | Pain: FLACC (0–10), FPS-R | 9 |
Notes. E: experimental group, C: control group, IV: intravenous, SCP: subcutaneous port, EMLA: eutectic mixture of local anesthetics, HPV: Human papillomavirus, IRB: institutional review board, RCT: randomized controlled trial, Quasi: quasi-experimental design, PSP: playstation portable, Ditto-D: ditto distraction, Ditto-PP: ditto procedural preparation, Ditto-C: ditto combined procedural preparation and distraction, RA: research assistant, WB-FACES: Wong Baker faces pain rating scale., CFS: children’s fear scale, NRS: numerical rating scale, VAS: visual analogue scale, FPS-R: face pain scale—revised, OSBD-R: observational scale of behavioral distress—revised, FLACC: face, legs, activity, crying and consolability behavioral scale, PRCD: parent report of child distress, MBPS: modified behavior pain scale, MAISD: measure of adult and infant soothing and distress, CAPS: children’s anxiety and pain scales, FPS: faces pain scale, BAADS: behavioral approach-avoidance scale, CAS: colored analogue scale, PCS-C: pain catastrophizing scale for children, CSS: child stress scale, WB-FPS: Wong-Baker faces pain rating scale, CEMS: children’s emotional manifestation scale, OSBD-A: amended observation scale of behavioral distress.